Trial reportCirculation2017
Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies.
3 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Circulation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 67 papers, 8 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 8 pooled it
24.8field-weighted citation impact, top 1% of its field
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
ILLUMENATE Pivotal: ProspectIve, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon
ProspectIve, SingLe-Arm, MuLti-Center, Pharmacokinetic Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon
Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial
Who cites it
67 citing papers in PubMed, 8 syntheses or guidelines pooled it, 211 citations in OpenAlex.
- Diversity in randomized clinical trials for peripheral artery disease: a systematic review.International journal for equity in health · 2024Pooled it
- Endovascular revascularization strategies for aortoiliac and femoropopliteal artery disease: a meta-analysis.European heart journal · 2023Pooled it
- Safety of paclitaxel-coated devices in the femoropopliteal arteries: A systematic review and meta-analysis.PloS one · 2022Pooled it
- Update on paclitaxel for femoral-popliteal occlusive disease in the 15 months following a summary level meta-analysis demonstrated increased risk of late mortality and dose response to paclitaxel.Journal of vascular surgery · 2021Pooled it
- Comparison of efficacy and safety of drug-eluting versus uncoated balloon angioplasty for femoropopliteal arterial occlusive disease: a meta-analysis.BMC cardiovascular disorders · 2020Pooled it
- Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis.Circulation · 2020Pooled it
- Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years.Circulation · 2019Pooled it
- Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Journal of the American Heart Association · 2018Pooled it
- Temsirolimus Adventitial Delivery to Improve ANGiographic Outcomes Below the Knee.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2024Trial
- Five-Year Outcomes after Paclitaxel Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Diabetic and Chronic Limb-Threatening Ischemia Cohorts: IN.PACT Global Study Post Hoc Analysis.Cardiovascular and interventional radiology · 2023Trial
- Methodology of the BIOPACT RCT, a Multi-center, Randomized, Non-inferiority Trial Evaluating Safety and Efficacy of Passeo-18 Lux Drug-Coated Balloon (DCB) of Biotronik Compared to the Medtronic IN.PACT Admiral DCB in the Treatment of Subjects with Lesions of the Femoropopliteal Artery.Cardiovascular and interventional radiology · 2022Trial
- The RANGER II superficial femoral artery trial: 1-year results of the long lesion cohort.Vascular medicine (London, England) · 2022Trial
- One-year results for Japanese patients in RANGER II SFA.Heart and vessels · 2022Trial
- Drug-eluting balloon (DEB) versus plain old balloon angioplasty (POBA) in the treatment of failing dialysis access: A prospective randomized trial.The Journal of international medical research · 2022Trial
- 24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the Zilver PTX Drug-Coated Stent.Cardiovascular and interventional radiology · 2021Trial
- Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2020Trial
- Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2020Trial
- COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions.European heart journal · 2020Trial
- Multivariable Regression Analysis of Clinical Data from the Randomized-Controlled EffPac Trial: Efficacy of Femoropopliteal Drug-Coated Balloon Angioplasty.Cardiovascular and interventional radiology · 2020Trial
- IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2019Trial
7 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 17 institutions in 6 countries.
Prakash KrishnanFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.). prakash.krishnan@mountsinai.org.
Peter FariesFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
Khusrow NiaziFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
Ash JainFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
Ravish SacharFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
William B BachinskyFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
Joseph CardenasFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
Martin WernerFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
Marianne BrodmannFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
J A MustaphaFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
Carlos Mena-HurtadoFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
Michael R JaffFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
Andrew H HoldenFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
Sean P LydenFrom Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).
Medical University of Graz · ATMassachusetts General Hospital · USMount Sinai Hospital · USUniversity of Michigan–Ann Arbor · USVienna General Hospital · ATBarry Callebaut (Belgium) · BECenteno-Schultz Clinic · USChrist University · INCrowder College · USGoodwin College · USMetro Health Hospital · USMiller College · USRichard Wolf (Germany) · DERiverbank Local Redevelopment Authority · USSchüßler-Plan (Germany) · DESt Christopher's Hospice · GBYale University · US
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDrug-coated balloons (DCBs) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Because of the differences in excipients, paclitaxel dose, and coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of 2 studies investigating the pharmacokinetic and clinical outcomes of a new DCB to treat femoropopliteal disease.
methodsIn the ILLUMENATE Pivotal Study (Prospective, Randomized, Single-Blind, U.S. Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon), 300 symptomatic patients (Rutherford class 2-4) were randomly assigned to DCB (n=200) or standard angioplasty (percutaneous transluminal angioplasty [PTA]) (n=100). The primary safety end point was freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months. The primary effectiveness end point was primary patency through 12 months. In the ILLUMENATE PK study (Pharmacokinetic Study of the Stellarex Drug-Coated Angioplasty Balloon), paclitaxel plasma concentrations were measured after last DCB deployment and at prespecified times (at 1, 4, 24 hours and at 7 and 14 days postprocedure) until no longer detectable.
resultsIn the ILLUMENATE Pivotal Study, baseline characteristics were similar between groups: 50% had diabetes mellitus, 41% were women, mean lesion length was 8.3 cm, and 44% were severely calcified. The primary safety end point was met (92.1% for DCB versus 83.2% for PTA,
conclusionsThe data demonstrate superior safety and effectiveness of the Stellarex DCB in comparison with PTA, and plasma levels of paclitaxel fall to low levels within 1 hour. CLINICAL
trial registrationURL: http://clinicaltrials.gov. Unique identifiers: NCT01858428 and NCT01912937.
Indexed as
Angioplasty, BalloonAgedCardiovascular AgentsCoated Materials, BiocompatibleFemaleFemoral ArteryHalf-LifeHumansKaplan-Meier EstimateMaleMiddle AgedPaclitaxelPeripheral Arterial DiseaseProspective StudiesSeverity of Illness IndexSingle-Blind MethodCardiovascular AgentsCoated Materials, BiocompatiblePaclitaxelangioplastydrug-eluting balloonfemoropoplitealintermittent claudicationpaclitaxelperipheral arterial disease
Identifiers
What Socratic holds
Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.