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CVI Drug Coated Balloon European Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT01858363
Recruitment Status : Active, not recruiting
First Posted : May 21, 2013
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Peripheral Arterial Disease Claudication Device: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter Device: Bare Percutaneous Transluminal Angioplasty Balloon Catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : November 2012
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Primary Efficacy Endpoint [ Time Frame: 12 months ]
    Primary Patency at 12 months post-procedure

  2. Primary Safety Endpoint [ Time Frame: 30-Days and 12-Months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858363


Locations
Germany
Center for Diagnostic Radiology and Minimally Invasive Therapy
Berlin, Germany
Sponsors and Collaborators
Spectranetics Corporation
Investigators
Principal Investigator: Henrik Schroeder, M.D. Center for Diagnostic Radiology & Minimally Invasive Therapy, The Jewish Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT01858363     History of Changes
Other Study ID Numbers: TP 1360
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Spectranetics Corporation:
Peripheral arterial disease
claudication
drug-coated balloon
drug-eluting balloon

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action