MedTrace Logo

Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis

NCT01330628 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2016-08-18

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Turbo Elite Laser and Turbo Tandem Laser Guide Catheters

application of laser energy to remove blockage followed by standard balloon angioplasty

PROCEDURE

Balloon angioplasty

standard balloon catheters for PTA

Sponsors & Collaborators

  • Spectranetics Corporation

    lead INDUSTRY

Principal Investigators

  • Eric J Dippel, MD · Genesis Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-03-31
Completion
2015-05-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01330628 on ClinicalTrials.gov