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Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4

NCT01632371 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2016-11-21

No results posted yet for this study

Summary

The purpose of the study is to determine whether scoring balloon (SCB) plus paclitaxel-coated balloon (PCB) is superior to PCB alone for the treatment of restenosis within "limus"-eluting stents (LES)

Conditions

  • Restenosis
  • Stable Angina Pectoris
  • Acute Coronary Syndrome

Interventions

DEVICE

Paclitaxel Eluting Balloon + Scoring Balloon

Scoring/cutting balloon lesion predilation; paclitaxel eluting balloon therapy

DEVICE

Paclitaxel Eluting Balloon

Standard balloon lesion predilation; paclitaxel-eluting balloon therapy

Sponsors & Collaborators

  • Biotronik AG

    collaborator INDUSTRY

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Adnan Kastrati, MD · Deutsches Herzzentrum Munich

  • Robert Byrne, MB PhD · Deutsches Herzzentrum Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-08-31
Completion
2016-11-30

Countries

  • Germany

Study Locations

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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 NCT01632371 on ClinicalTrials.gov