Overview

This trial is active, not recruiting.

Conditions peripheral arterial disease, claudication
Treatments cvi paclitaxel-coated percutaneous transluminal angioplasty balloon catheter, bare percutaneous transluminal angioplasty balloon catheter
Sponsor Spectranetics Corporation
Start date November 2012
End date March 2016
Trial size 360 participants
Trial identifier NCT01858363, TP 1360

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
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.
cvi paclitaxel-coated percutaneous transluminal angioplasty balloon catheter
(Placebo Comparator)
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.
bare percutaneous transluminal angioplasty balloon catheter

Primary Outcomes

Measure
Primary Efficacy Endpoint
time frame: 12 months
Primary Safety Endpoint
time frame: 30-Days and 12-Months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Henrik Schroeder, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Spectranetics Corporation.