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

San Donato Group (GSD)

Status and phase

Terminated

Phase 4

Conditions

Unstable Angina

Stable Angina

Treatments

Device: Paclitaxel-eluting Stent

Procedure: Paclitaxel-coated Balloon

Study type

Interventional

Funder types

Other

Identifiers

NCT01204320

Arezzo003

Details and patient eligibility

About

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.

Full 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.

Enrollment

154 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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