A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)
NCT ID: NCT01204320
Last Updated: 2010-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
154 participants
INTERVENTIONAL
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Paclitaxel-coated Balloon
Paclitaxel-coated Balloon Angioplasty
Paclitaxel-coated Balloon
POBA
Paclitaxel-eluting Stent
Paclitaxel-eluting Stent Implantation
Paclitaxel-eluting Stent
Stenting
Interventions
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Paclitaxel-coated Balloon
POBA
Paclitaxel-eluting Stent
Stenting
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>18y
* Stable Angina or Unstable Angina
* Single restenotic lesion in a previously stented coronary artery
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ospedale San Donato
OTHER
Responsible Party
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Ospedale SanDonato
Principal Investigators
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Leonardo Bolognese, MD
Role: STUDY_CHAIR
Cardiovascular Department - San Donato Hospital
Locations
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San Donato Hospital
Arezzo, AR, Italy
Countries
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Other Identifiers
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Arezzo003
Identifier Type: -
Identifier Source: org_study_id