Stable Angina Clinical Trial
— COMPACT-ISRVerified date | October 2009 |
Source | Ospedale San Donato |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 154 |
Est. completion date | |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | San Donato Hospital | Arezzo | AR |
Lead Sponsor | Collaborator |
---|---|
Ospedale San Donato |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis | 6 months | No | |
Secondary | Binary restenosis defined as >50% diameter stenosis by QCA | 6 months | No | |
Secondary | Major Adverse Cardiac Events | 6, 12 months | Yes | |
Secondary | Target Lesion Revascularization | 6, 12 months | Yes |
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