Evidence map›Paper›PMID 25744011›Full record

ArticleJournal of the American College of Cardiology2015

Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC).

Manesh R Patel, Michael S Conte, Donald E Cutlip, Nabil Dib, Patrick Geraghty, William Gray, William R Hiatt, Mami Ho, Koji Ikeda, Fumiaki Ikeno and 20 more

Erratum issued 2 registry-linked trialsOpen access · greenAbstract readConsensus Statement
In one paragraph

Article in Journal of the American College of Cardiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 123 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
123citing papers in PubMed, 7 pooled it
22.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT03241459 nacompletednot on this mapstarted 2017, after this paper: background citation

Randomized & Controlled Noninferiority Trial to Evaluate Safety & Clinical Efficacy of SurVeil™ Drug-Coated Balloon (DCB) iN Treatment of Subjects With Stenotic Lesions of Femoropopliteal Artery Compared to Medtronic IN.PACT® Admiral® DCB

TypeinterventionalSponsorSurModics, Inc.Ran2017 to 2024Enrolled446ConditionsPeripheral Arterial Disease, Peripheral Vascular Disease, Artery Disease, Peripheral, Femoropopliteal Artery OcclusionArmsSurmodics SurVeil DCB, Medtronic IN.PACT Admiral DCB
NCT05916950 narecruitingnot on this mapstarted 2024, after this paper: background citation

The THOR IDE Study

TypeinterventionalSponsorPhilips Clinical & Medical Affairs GlobalRan2024 to 2027Enrolled155ConditionsPeripheral Artery Disease, Peripheral Artery Stenosis, Peripheral Artery Calcification, PADArmsThor laser atherectomy
3 · Its place in the literature

Who cites it

123 citing papers in PubMed, 7 syntheses or guidelines pooled it, 361 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. SCAI guidelines on device selection in Aorto-Iliac arterial interventions.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2020
    Guideline
  4. Guideline
  5. Guideline
  6. Prostanoids for critical limb ischaemia.The Cochrane database of systematic reviews · 2018
    Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Article
  13. Article
  14. Device design and applications of the novel JAVELIN peripheral intravascular lithotripsy catheter.Journal of vascular surgery cases and innovative techniques · 2026
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Observational

63 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

30 authors at 20 institutions in 4 countries.

Manesh R PatelDuke Clinical Research Institute, Duke University, Durham, North Carolina. Electronic address: manesh.patel@duke.edu.
Michael S ConteUniversity of California-San Francisco, San Francisco, California.
Donald E CutlipHarvard Clinical Research Institute, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Nabil DibUniversity of California-San Diego, San Diego, California.
Patrick GeraghtyWashington University Medical School, St. Louis, Missouri.
William GrayCardiovascular Research Foundation, New York, New York; Columbia University Medical Center, New York, New York.
William R HiattUniversity of Colorado School of Medicine, and CPC Clinical Research, Aurora, Colorado.
Mami HoOffice of Medical Devices I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Koji IkedaTohoku University Hospital, Sendai City, Miyagi, Japan.
Fumiaki IkenoStanford University, Palo Alto, California.
Michael R JaffVasCore, Massachusetts General Hospital, Boston, Massachusetts.
W Schuyler JonesDuke Clinical Research Institute, Duke University, Durham, North Carolina.
Masayuki KawaharaOffice of Medical Devices I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Robert A LooksteinMount Sinai Medical Center, New York, New York.
Roxana MehranCardiovascular Research Foundation, New York, New York; Mount Sinai Medical Center, New York, New York.
Sanjay MisraMayo Clinic, Rochester, Minnesota.
Lars NorgrenUniversity Hospital, Orebro, Sweden.
Jeffrey W OlinMount Sinai Medical Center, New York, New York.
Thomas J PovsicDuke Clinical Research Institute, Duke University, Durham, North Carolina.
Kenneth RosenfieldMassachusetts General Hospital, Boston, Massachusetts.
John RundbackHoly Name Medical Center, Teaneck, New Jersey.
Fadi ShamounMayo Clinic Arizona, Phoenix, Arizona.
James TchengDuke Clinical Research Institute, Duke University, Durham, North Carolina.
Thomas T TsaiKaiser Permanente Colorado Institute for Health Research, University of Colorado, Denver, Colorado.
Yuka SuzukiOffice of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Pascal VranckxCardialysis, Rotterdam, the Netherlands.
Bret N WiechmannVascular and Interventional Physicians, Gainesville, Florida.
Christopher J WhiteOchsner Medical Center, New Orleans, Louisiana.
Hiroyoshi YokoiKokura Memorial Hospital, Kitakyuku, Japan.
Mitchell W KrucoffDuke Clinical Research Institute, Duke University, Durham, North Carolina.
Duke University · USMount Sinai Medical Center · USPharmaceuticals and Medical Devices Agency · JPMassachusetts General Hospital · USUniversity of Colorado Denver · USBeth Israel Deaconess Medical Center · USCardialysis (Netherlands) · NLColumbia University Irving Medical Center · USHoly Name Medical Center · USKokura Memorial Hospital · JPMayo Clinic · USMayo Clinic Hospital · USOchsner Medical Center · USÖrebro University Hospital · SEPalo Alto University · USSociety of Interventional Radiology · USTohoku University Hospital · JPUniversity of California San Diego · USUniversity of California, San Francisco · USWashington University in St. Louis · US

Funding

The Role of Hypoxia In Venous Neointimal Hyperplasia In Hemodialysis GraftsR01HL098967 · NHLBI · MAYO CLINIC ROCHESTER · PI Sanjay Misra · 2010 to 2026
$10.4M
NHLBI NIH HHS R01 HL098967
6 · The paper itself

Abstract

The lack of consistent definitions and nomenclature across clinical trials of novel devices, drugs, or biologics poses a significant barrier to accrual of knowledge in and across peripheral artery disease therapies and technologies. Recognizing this problem, the Peripheral Academic Research Consortium, together with the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, has developed a series of pragmatic consensus definitions for patients being treated for peripheral artery disease affecting the lower extremities. These consensus definitions include the clinical presentation, anatomic depiction, interventional outcomes, surrogate imaging and physiological follow-up, and clinical outcomes of patients with lower-extremity peripheral artery disease. Consistent application of these definitions in clinical trials evaluating novel revascularization technologies should result in more efficient regulatory evaluation and best practice guidelines to inform clinical decisions in patients with lower extremity peripheral artery disease.

Indexed as

AngioplastyAtherectomyBlood Vessel ProsthesisConstriction, PathologicDiagnostic ImagingEndarterectomyHumansLower ExtremityPatient Outcome AssessmentPeripheral Arterial DiseaseQuality of LifeSeverity of Illness IndexStentsWalkingamputationfootintermittent claudicationlegmyocardial infarctionstroke

Identifiers

PMID25744011
PMCPMC4874808
OpenAlexW76788954

What Socratic holds

Textmetadata
LicenceTDM
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.