We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

CVI Drug Coated Balloon European Randomized Clinical Trial

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01858363
First Posted: May 21, 2013
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Spectranetics Corporation
  Purpose
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 Claudication Device: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter Device: Bare Percutaneous Transluminal Angioplasty Balloon Catheter

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Spectranetics Corporation:

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

  • 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


Estimated Enrollment: 360
Study Start Date: November 2012
Estimated Study Completion Date: June 2020
Primary Completion Date: March 2016 (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT01858363     History of Changes
Other Study ID Numbers: TP 1360
First Submitted: May 8, 2013
First Posted: May 21, 2013
Last Update Posted: November 10, 2017
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