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Clinical Trials/NCT01204320
NCT01204320
Terminated
Phase 4

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

Ospedale San Donato1 site in 1 country154 target enrollmentJanuary 2008
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ConditionsStable AnginaUnstable Angina

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Stable Angina
Sponsor
Ospedale San Donato
Enrollment
154
Locations
1
Primary Endpoint
Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis
Status
Terminated
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
January 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •informed consent
  • •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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Major Adverse Cardiac Events(6, 12 months)
  • Target Lesion Revascularization(6, 12 months)
  • Binary restenosis defined as >50% diameter stenosis by QCA(6 months)

Study Sites (1)

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