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

Phase 4

Terminated

• Conditions: Unstable Angina; Stable Angina
• Interventions: Device: Paclitaxel-eluting Stent; Procedure: Paclitaxel-coated Balloon

• Registration Number: NCT01204320
• Lead Sponsor: Ospedale San Donato

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.

Study Timeline

• Study Start: 2008-01
• Status Verified: 2009-10
• Primary Completion: 2010-01
• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-16
• Last Update Submitted: 2010-09-16
• Study First Posted: 2010-09-17
• Last Update Posted: 2010-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel-eluting Stent	Paclitaxel-eluting Stent	Paclitaxel-eluting Stent Implantation
Paclitaxel-coated Balloon	Paclitaxel-coated Balloon	Paclitaxel-coated Balloon Angioplasty

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	6, 12 months
Target Lesion Revascularization	6, 12 months
Binary restenosis defined as >50% diameter stenosis by QCA	6 months

Trial Locations

Locations (1)

San Donato Hospital; 🇮🇹 Arezzo, AR, Italy