A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR) (COMPACT-ISR)

September 16, 2010 updated by: Ospedale San Donato
This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the evaluation of restenosis by Quantitative Coronary Analysis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine the late luminal loss by Quantitative Coronary Analysis at 6 month-follow up after paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in the treatment of in-stent restenosis.

Study Type

Interventional

Enrollment (Anticipated)

154

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AR
      • Arezzo, AR, Italy, 52100
        • San Donato Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • informed consent
  • >18y
  • Stable Angina or Unstable Angina
  • Single restenotic lesion in a previously stented coronary artery

Exclusion Criteria:

  • Acute Myocardial Infarction within 72h
  • Serum Creatinine>2.0 mg/dL
  • Contraindications to ASA, Heparin, Clopidogrel, Ticlopidine, Abciximab, Tirofiban, Paclitaxel
  • Contraindications to contrast media
  • Life expectancy < 2y
  • Target Lesion length > 30mm
  • Target Lesion diameter <= 2.5 mm
  • Target stenosis < 70%
  • Massive Calcifications in the target segment
  • Evidence of intra-coronary thrombus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel-coated Balloon
Paclitaxel-coated Balloon Angioplasty
Procedure: Paclitaxel-coated Balloon
POBA
Other Names:
  • Orbus
Active Comparator: Paclitaxel-eluting Stent
Paclitaxel-eluting Stent Implantation
Device: Paclitaxel-eluting Stent
Stenting
Other Names:
  • Taxus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Binary restenosis defined as >50% diameter stenosis by QCA
Time Frame: 6 months
6 months
Major Adverse Cardiac Events
Time Frame: 6, 12 months
6, 12 months
Target Lesion Revascularization
Time Frame: 6, 12 months
6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Donato

Investigators

  • Study Chair: Leonardo Bolognese, MD, Cardiovascular Department - San Donato Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

September 16, 2010

First Submitted That Met QC Criteria

September 16, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Estimate)

September 17, 2010

Last Update Submitted That Met QC Criteria

September 16, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arezzo003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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