Back to resultsA COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR) (COMPACT-ISR)
Primary Purpose
Stable Angina, Unstable Angina
Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Paclitaxel-coated Balloon
Paclitaxel-eluting Stent
Sponsored by
About this trial
This is an interventional treatment trial for Stable Angina focused on measuring Restenosis, POBA, Stenting, Paclitaxel
Eligibility Criteria
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
Sites / Locations
- San Donato Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Paclitaxel-coated Balloon
Paclitaxel-eluting Stent
Arm Description
Paclitaxel-coated Balloon Angioplasty
Paclitaxel-eluting Stent Implantation
Outcomes
Primary Outcome Measures
Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis
Secondary Outcome Measures
Binary restenosis defined as >50% diameter stenosis by QCA
Major Adverse Cardiac Events
Target Lesion Revascularization
Full Information
NCT ID
NCT01204320
First Posted
September 16, 2010
Last Updated
September 16, 2010
Sponsor
Ospedale San Donato
1. Study Identification
Unique Protocol Identification Number
NCT01204320
Brief Title
A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)
Acronym
COMPACT-ISR
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ospedale San Donato
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Unstable Angina
Keywords
Restenosis, POBA, Stenting, Paclitaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel-coated Balloon
Arm Type
Experimental
Arm Description
Paclitaxel-coated Balloon Angioplasty
Arm Title
Paclitaxel-eluting Stent
Arm Type
Active Comparator
Arm Description
Paclitaxel-eluting Stent Implantation
Intervention Type
Procedure
Intervention Name(s)
Paclitaxel-coated Balloon
Other Intervention Name(s)
Orbus
Intervention Description
POBA
Intervention Type
Device
Intervention Name(s)
Paclitaxel-eluting Stent
Other Intervention Name(s)
Taxus
Intervention Description
Stenting
Primary Outcome Measure Information:
Title
Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Binary restenosis defined as >50% diameter stenosis by QCA
Time Frame
6 months
Title
Major Adverse Cardiac Events
Time Frame
6, 12 months
Title
Target Lesion Revascularization
Time Frame
6, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Bolognese, MD
Organizational Affiliation
Cardiovascular Department - San Donato Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
San Donato Hospital
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)
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