Status:
TERMINATED
A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)
Lead Sponsor:
Ospedale San Donato
Conditions:
Stable Angina
Unstable Angina
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 re...
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 implantat...
Eligibility Criteria
Inclusion
- informed consent
- \>18y
- Stable Angina or Unstable Angina
- Single restenotic lesion in a previously stented coronary artery
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT01204320
Start Date
January 1 2008
Last Update
September 17 2010
Active Locations (1)
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1
San Donato Hospital
Arezzo, AR, Italy, 52100