Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

CVI Drug Coated Balloon European Randomized Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Covidien
Information provided by (Responsible Party):
Covidien Identifier:
First received: May 8, 2013
Last updated: February 12, 2014
Last verified: February 2014

This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.

Condition Intervention
Peripheral Arterial Disease
Device: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Device: Bare Percutaneous Transluminal Angioplasty Balloon Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Primary Efficacy Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Primary Patency at 12 months post-procedure

  • Primary Safety Endpoint [ Time Frame: 30-Days and 12-Months ] [ Designated as safety issue: Yes ]
    Freedom from device and procedure related target limb major amputation or death through 30-days post-procedure and clinically-driven target lesion revascularization at 12-month

Estimated Enrollment: 360
Study Start Date: November 2012
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel-coated balloon
Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.
Device: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Placebo Comparator: Bare balloon
Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.
Device: Bare Percutaneous Transluminal Angioplasty Balloon Catheter


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptomatic leg ischemia requiring treatment of the superficial femoral or popliteal arteries
  • Rutherford clinical category 2, 3 or 4
  • Male or non-pregnant female at least 18 years

Exclusion Criteria:

  • Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries
  • Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
  • Known intolerance of study medications, paclitaxel or contrast agent
  • Active participation in another investigational device or drug study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01858363

Contact: Amaëlle Vuillaume

Center for Diagnostic Radiology and Minimally Invasive Therapy Recruiting
Berlin, Germany
Principal Investigator: Henrik Schroeder, M.D         
Sponsors and Collaborators
Principal Investigator: Henrik Schroeder, M.D. Center for Diagnostic Radiology & Minimally Invasive Therapy, The Jewish Hospital
  More Information

No publications provided

Responsible Party: Covidien Identifier: NCT01858363     History of Changes
Other Study ID Numbers: TP 1360
Study First Received: May 8, 2013
Last Updated: February 12, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Covidien:
Peripheral arterial disease
drug-coated balloon
drug-eluting balloon

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on February 27, 2015