Evidence map›Paper›PMID 28424223›Full record

Trial reportCirculation2017

Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon).

Henrik Schroeder, Martin Werner, Dirk-Roelfs Meyer, Peter Reimer, Karsten Krüger, Michael R Jaff, Marianne Brodmann, ILLUMENATE EU RCT Investigators

2 registry-linked trialsOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 2 registered trials, which are not on this map. Cited by 41 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 8 pooled it
20.1field-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.

NCT01858363 nacompletednot on this map

Prospective, Randomized, Multi-center, Single-blinded Study for the Treatment of Subjects Presenting With De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using Paclitaxel or Bare Percutaneous Transluminal Angioplasty Balloon Catheter

TypeinterventionalSponsorSpectranetics CorporationRan2012 to 2020Enrolled294ConditionsPeripheral Arterial Disease, ClaudicationArmsCVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter, Bare Percutaneous Transluminal Angioplasty Balloon Catheter
NCT02212470 phase4completednot on this map

Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial

TypeinterventionalSponsorInstituto Dante Pazzanese de CardiologiaRan2014 to 2019Enrolled85ConditionsPeripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, ArteriosclerosisArmsDrug Eluting Balloon Angioplasty, Nitinol stenting
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 8 syntheses or guidelines pooled it, 142 citations in OpenAlex.

  1. Pooled it
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  5. Atherectomy for peripheral arterial disease.The Cochrane database of systematic reviews · 2020
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Trial
  10. 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 · 2020
    Trial
  11. Trial
  12. Trial
  13. 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 · 2019
    Trial
  14. Trial
  15. Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2018
    Trial
  16. Trial
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  18. Review
  19. Major Adverse Limb Events and Death After Successful Endovascular Revascularization: BEST-CLI Trial.Journal of the Society for Cardiovascular Angiography & Interventions · 2026
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 3 countries.

Henrik SchroederFrom Center for Diagnostic Radiology and Minimally Invasive Therapy, The Jewish Hospital, Berlin, Germany (H.S.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D.-R.M.); Institute for Diagnostic and Interventional Radiology, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (P.R.); Department of Radiology and Interventional Therapy, Vivantes Humboldt Hospital, Berlin, Germany (K.K.); Department of Radiology and Interventional Therapy, Vivantes Hospital Spandau, Berlin, Germany (K.K.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); and Department of Angiology, Medical University Graz, Austria (M.B.). henrik.schroeder@ihre-radiologen.de.
Martin WernerFrom Center for Diagnostic Radiology and Minimally Invasive Therapy, The Jewish Hospital, Berlin, Germany (H.S.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D.-R.M.); Institute for Diagnostic and Interventional Radiology, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (P.R.); Department of Radiology and Interventional Therapy, Vivantes Humboldt Hospital, Berlin, Germany (K.K.); Department of Radiology and Interventional Therapy, Vivantes Hospital Spandau, Berlin, Germany (K.K.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); and Department of Angiology, Medical University Graz, Austria (M.B.).
Dirk-Roelfs MeyerFrom Center for Diagnostic Radiology and Minimally Invasive Therapy, The Jewish Hospital, Berlin, Germany (H.S.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D.-R.M.); Institute for Diagnostic and Interventional Radiology, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (P.R.); Department of Radiology and Interventional Therapy, Vivantes Humboldt Hospital, Berlin, Germany (K.K.); Department of Radiology and Interventional Therapy, Vivantes Hospital Spandau, Berlin, Germany (K.K.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); and Department of Angiology, Medical University Graz, Austria (M.B.).
Peter ReimerFrom Center for Diagnostic Radiology and Minimally Invasive Therapy, The Jewish Hospital, Berlin, Germany (H.S.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D.-R.M.); Institute for Diagnostic and Interventional Radiology, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (P.R.); Department of Radiology and Interventional Therapy, Vivantes Humboldt Hospital, Berlin, Germany (K.K.); Department of Radiology and Interventional Therapy, Vivantes Hospital Spandau, Berlin, Germany (K.K.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); and Department of Angiology, Medical University Graz, Austria (M.B.).
Karsten KrügerFrom Center for Diagnostic Radiology and Minimally Invasive Therapy, The Jewish Hospital, Berlin, Germany (H.S.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D.-R.M.); Institute for Diagnostic and Interventional Radiology, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (P.R.); Department of Radiology and Interventional Therapy, Vivantes Humboldt Hospital, Berlin, Germany (K.K.); Department of Radiology and Interventional Therapy, Vivantes Hospital Spandau, Berlin, Germany (K.K.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); and Department of Angiology, Medical University Graz, Austria (M.B.).
Michael R JaffFrom Center for Diagnostic Radiology and Minimally Invasive Therapy, The Jewish Hospital, Berlin, Germany (H.S.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D.-R.M.); Institute for Diagnostic and Interventional Radiology, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (P.R.); Department of Radiology and Interventional Therapy, Vivantes Humboldt Hospital, Berlin, Germany (K.K.); Department of Radiology and Interventional Therapy, Vivantes Hospital Spandau, Berlin, Germany (K.K.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); and Department of Angiology, Medical University Graz, Austria (M.B.).
Marianne BrodmannFrom Center for Diagnostic Radiology and Minimally Invasive Therapy, The Jewish Hospital, Berlin, Germany (H.S.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D.-R.M.); Institute for Diagnostic and Interventional Radiology, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (P.R.); Department of Radiology and Interventional Therapy, Vivantes Humboldt Hospital, Berlin, Germany (K.K.); Department of Radiology and Interventional Therapy, Vivantes Hospital Spandau, Berlin, Germany (K.K.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); and Department of Angiology, Medical University Graz, Austria (M.B.).
ILLUMENATE EU RCT Investigators
University of Freiburg · DEHanusch Hospital · ATVivantes Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNumerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials, with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2-µg/mm

methodsThis was a prospective, randomized, multicenter, single-blinded trial. Patients were randomized (3:1) to treatment with a low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety end point was a composite of freedom from device- and procedure-related death through 30 days after the procedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months after the procedure. The primary effectiveness end point was primary patency at 12 months.

resultsPatients were randomized to treatment with a DCB (222 patients, 254 lesions) or uncoated PTA balloon (72 patients, 79 lesions) after successful predilatation. Mean lesion length was 7.2 and 7.1 cm, and 19.2% and 19.0% of lesions represented total occlusions, respectively. The primary safety end point was met, and superiority was demonstrated; freedom from a primary safety event was 94.1% (193 of 205) with DCB and 83.3% (50 of 60) with PTA, for a difference of 10.8% (95% confidence interval, 0.9%-23.0%). The primary effectiveness end point was met, and superiority of DCB over PTA was achieved (83.9% [188 of 224] versus 60.6% [40 of 66];

conclusionsSuperiority with a low-dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness end points. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01858363.

Indexed as

AgedAngioplastyAngioplasty, BalloonCoated Materials, BiocompatibleEuropeFemaleFemoral ArteryFollow-Up StudiesHumansMaleMiddle AgedPaclitaxelPeripheral Arterial DiseasePopliteal ArteryProspective StudiesSingle-Blind MethodCoated Materials, BiocompatiblePaclitaxeldrug-eluting balloonpaclitaxelpercutaneous treatmentperipheral artery diseaserandomized controlled trial

Identifiers

PMID28424223
PMCPMC5459585
OpenAlexW2606784939

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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 OpenQuestion graph.