Status:
UNKNOWN
GISSOC II: Sirolimus Eluting Stent Versus Bare Metal Stent in Chronic Total Coronary Occlusions
Lead Sponsor:
Società Italiana di Cardiologia Invasiva
Collaborating Sponsors:
Cordis Italy a division of Johnson & Johnson Medical SpA
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to compare the Cypher Select-TM Sirolimus Eluting Stent (SES) with the SONIC-TM Bare Metal Stent (BMS) in the treatment of Chronic Total Occlusion lesions (CTO). The pri...
Detailed Description
This is a multicenter, prospective, randomized study that will be conducted at up to 22 centers in Italy. All patients who meet the eligibility criteria will be randomized to Cypher Select-TM Stent or...
Eligibility Criteria
Inclusion
- Stable or unstable angina pectoris or documented silent ischemia;
- Planned treatment of a single de novo chronic totally occluded (CTO) in a native coronary artery with a reference diameter between 2.75 mm and 3.75 mm;
- The target lesion can be fully covered by ≤ 2 stents of ≤33 mm of length each;
- The target CTO is at least 30 days old;
- The target CTO is successfully crossed by a guide wire and dilated by a balloon;
Exclusion
- Myocardial infarction within 30 days in the territory of the target CTO;
- Unprotected left main coronary artery disease;
- Target CTO is in a graft;
- Target CTO is in a stented segment;
- Presence of other lesions in the same vessel,requiring angioplasty and not treatable with the same stent(s) used for the target CTO;
- More than one CTO requiring PCI;
- Target CTO has diseased side branches \>2.0 mm in diameter;
- Target CTO pretreated with non-balloon devices such as atherectomy or laser or thrombectomy devices;
- Patient treated with coronary brachytherapy;
- The patient has an ejection fraction ≤ 30%;
- The patient has impaired renal function (creatinine \> 3.0 mg/dl);
- The patient has known allergies to aspirin, clopidogrel bisulfate and ticlopidine, heparin, or sirolimus, contrast media or stainless steel that cannot be managed medically;
- The patient needs therapy with warfarin;
- The patient has a life expectancy less than 24 months;
- Recipient of heart transplant;
- The patient is currently participating in an investigational drug or another device study.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00220558
Start Date
May 1 2005
End Date
February 1 2010
Last Update
December 4 2009
Active Locations (14)
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1
Ospedale San Donato
Arezzo, Italy, 52100
2
Cliniche Gavazzeni
Bergamo, Italy
3
Ospedale Sant'Orsola-Malpighi
Bologna, Italy, 40138
4
Ospedale Vittorio Emanuele
Catania, Italy, 95124