Back to resultsA Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions. (TROPICAL)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
drug-eluting stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: The patient has an in-stent restenosis of ≥ 60% and < 100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery. The study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion. Exclusion Criteria: Unprotected left main coronary disease with ≥ 50% stenosis; Patient previously treated with brachytherapy in any coronary vessel. Target lesion involves bifurcation including a side branch >2.5mm in diameter. The patient sustained a recent (<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB or abnormal lab values.
Sites / Locations
- K.U. Leuven
- Herz-zentrum Bad Krozingen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Cypher™ sirolimus-eluting stent
Outcomes
Primary Outcome Measures
angiographic in-lesion late loss
Secondary Outcome Measures
in-stent mean percent diameter stenosis (%DS)
i-stent late loss (LL)
in-lesion binary restenosis
Target Vessel Revascularization (TVR)
Target Vessel Failure (TVF) defined as any revascularization of the index vessel or myocardial infarction or death that cannot be clearly attributed to a vessel other than the index vessel
Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization in-hospital
occurrence of bleeding
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00232856
Brief Title
A Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions.
Acronym
TROPICAL
Official Title
A Multi-Center, Non-Randomised Study of the CYPHER™ Sirolimus-Eluting Stent in the Treatment of Patient With an in-Stent Restenotic Native Coronary Artery Lesion
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of this study is to assess the safety and effectiveness of the Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.
Detailed Description
This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypher™ sirolimus-eluting stent. All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. The results of this study will be compared with the outcome of the GAMMA I / II as the historical control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Cypher™ sirolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
drug-eluting stent
Other Intervention Name(s)
Cypher™ sirolimus-eluting stent
Intervention Description
PCI
Primary Outcome Measure Information:
Title
angiographic in-lesion late loss
Time Frame
6 months post-procedure
Secondary Outcome Measure Information:
Title
in-stent mean percent diameter stenosis (%DS)
Time Frame
6-months post-procedure
Title
i-stent late loss (LL)
Time Frame
6 months post-procedure
Title
in-lesion binary restenosis
Time Frame
6-months post-procedure
Title
Target Vessel Revascularization (TVR)
Time Frame
9-months post-procedure
Title
Target Vessel Failure (TVF) defined as any revascularization of the index vessel or myocardial infarction or death that cannot be clearly attributed to a vessel other than the index vessel
Time Frame
9 months post-procedure
Title
Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization in-hospital
Time Frame
1, 6, 9 months and, 2 and 3 years post-procedure
Title
occurrence of bleeding
Time Frame
1, 6, 9 months and, 2 and 3 years post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient has an in-stent restenosis of ≥ 60% and < 100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery.
The study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion.
Exclusion Criteria:
Unprotected left main coronary disease with ≥ 50% stenosis;
Patient previously treated with brachytherapy in any coronary vessel.
Target lesion involves bifurcation including a side branch >2.5mm in diameter.
The patient sustained a recent (<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB or abnormal lab values.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franz-Josef Neumann, MD
Organizational Affiliation
Herz-zentrum Bad Krozingen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walter Desmet, MD
Organizational Affiliation
K.U. Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
K.U. Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Herz-zentrum Bad Krozingen
City
Bad-Krozingen
ZIP/Postal Code
78189
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions.
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