Coronary Artery Disease Clinical Trial
Official title:
A Randomized Comparison of Sirolimus Eluting Stent Versus Bare Metal Stent in Chronic Total Coronary Occlusions: The Gruppo Italiano di Studio Sullo Stent Nelle Occlusioni Coronariche. The GISSOC II Study.
Verified date | May 2009 |
Source | Società Italiana di Cardiologia Invasiva |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
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 primary hypothesis is that, at 8-month follow-up, the minimal luminal diameter (MLD) of the coronary segment treated with stent implantation in CTO lesions is significantly larger with the use of SES compared to BMS. The treated segment is defined as the segment covered by the stent(s) plus 5 mm proximally and distally to the stent(s).
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | February 2010 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale San Donato | Arezzo | |
Italy | Cliniche Gavazzeni | Bergamo | |
Italy | Ospedale Sant'Orsola-Malpighi | Bologna | |
Italy | Ospedale Vittorio Emanuele | Catania | |
Italy | Ospedale Sant'Anna | Como | |
Italy | Azienda Ospedaliera Villa Scassi | Genoa | |
Italy | Ospedale San Martino | Genova | |
Italy | Ospedale Civile di Legnano | Legnano | |
Italy | Ospedale Civile di Mestre | Mestre | |
Italy | Azienda Ospedaliera di Padova | Padova | |
Italy | Azienda Ospedaliera Pisana | Pisa | |
Italy | Arcispedale Santa Maria Nuova | Reggio Emilia | |
Italy | Ospedale San Giovanni Battista Università | Torino | |
Italy | Ospedale Cà Foncello | Treviso |
Lead Sponsor | Collaborator |
---|---|
Società Italiana di Cardiologia Invasiva | Cordis Italy a division of Johnson & Johnson Medical SpA |
Italy,
Hoye A, Tanabe K, Lemos PA, Aoki J, Saia F, Arampatzis C, Degertekin M, Hofma SH, Sianos G, McFadden E, van der Giessen WJ, Smits PC, de Feyter PJ, van Domburg RT, Serruys PW. Significant reduction in restenosis after the use of sirolimus-eluting stents in the treatment of chronic total occlusions. J Am Coll Cardiol. 2004 Jun 2;43(11):1954-8. — View Citation
Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. — View Citation
Rubartelli P, Niccoli L, Verna E, Giachero C, Zimarino M, Fontanelli A, Vassanelli C, Campolo L, Martuscelli E, Tommasini G. Stent implantation versus balloon angioplasty in chronic coronary occlusions: results from the GISSOC trial. Gruppo Italiano di Studio sullo Stent nelle Occlusioni Coronariche. J Am Coll Cardiol. 1998 Jul;32(1):90-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The minimal luminal diameter (MLD) at 8-month follow-up of the coronary segment treated with stent implantation in CTO lesions. The treated segment is defined as the segment covered by the stent(s) plus 5 mm proximally and distally to the stent(s). | 8 month | No | |
Secondary | - Major adverse cardiac events (MACE) rate at 30 days, 8, 12 and 24 months; | two years | Yes | |
Secondary | - In-segment late loss (LL) at 8 months; | 8 months | No | |
Secondary | - Binary restenosis rate in the treated coronary segment, defined as the rate of patients showing an in-segment diameter stenosis greater than 50% at 8 months; | eight month | No | |
Secondary | - In-segment total re-occlusion at 8 months; | 8 month | No | |
Secondary | - Target Lesion Revascularization (TLR) at 8 ,12 and 24 months; | two years | Yes | |
Secondary | - Target Vessel Revascularization (TVR) at 8 ,12 and 24 months; | two years | Yes | |
Secondary | - Angiographic success defined as achievement of a final residual diameter stenosis of < 30 % (by QCA)using the assigned study stent; | procedure date | No | |
Secondary | - Procedural success defined as angiographic success, without the occurrence of death, myocardial infarction (MI), or repeat revascularization of the target lesion during the hospital stay; | procedure date | No | |
Secondary | - Sub acute stent thrombosis defined as angiographic documentation <30 days after the index procedure (site-reported or by QCA) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel; | one month | Yes | |
Secondary | - Late stent thrombosis defined as angiographic documentation >30 days after the index procedure (site-reported or by QCA) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel. | two yeras | Yes |
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