MedTrace Logo

Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

NCT01495533 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-27

No results posted yet for this study

Summary

The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.

Conditions

  • In-stent Arterial Restenosis

Interventions

DEVICE

uncoated AngioSculpt(R)

Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)

COMBINATION_PRODUCT

Drug coated AngioSculpt(R)

Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)

Sponsors & Collaborators

  • University Hospital, Saarland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-12-31
Completion
2014-07-31

Countries

  • Brazil
  • Germany

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 NCT01495533 on ClinicalTrials.gov