Clinical Trial: GISSOC II: Sirolimus Eluting Stent Versus Bare Metal Stent in Chronic Total Coronary Occlusions

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 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).

Detailed Summary:

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 SONIC-TM Stent. Patients will have repeat angiography at 8 months and clinical follow-up to 2 years. The study population will consist of 150 patients with single chronic total occlusion in a native coronary artery with a reference diameter between 2.75 mm and 3.75 mm. The occlusion has to be dilatable by balloon angioplasty and can be fully covered by < 2 stents of ≤33 mm of length each. The CTO is defined as obstruction of a native coronary artery, at least 30 days old, with no luminal continuity and with Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 or 1. Following confirmation of eligibility criteria and successful pre-dilating of the CTO, patients will be randomized in a 1:1 ratio to receive SES CYPHER SELECT Stent or BMS SONIC Stent.

The coronary angiograms will be assessed at a core laboratory with Quantitative Coronary Angiography. Quantitative angiographic parameters including minimal luminal diameter, binary restenosis rate, total reocclusion rate, late luminal loss, will be evaluated at 8 months. The incidence of clinical events, including death, myocardial infarction, target vessel revascularization, stent thrombosis, will be evaluated at 8, 12 and 24 months.


Sponsor: Società Italiana di Cardiologia Invasiva

Current Primary Outcome: 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). [ Time Frame: 8 month ]

Original Primary Outcome: 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).

Current Secondary Outcome:

  • - Major adverse cardiac events (MACE) rate at 30 days, 8, 12 and 24 months; [ Time Frame: two years ]
  • - In-segment late loss (LL) at 8 months; [ Time Frame: 8 months ]
  • - 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; [ Time Frame: eight month ]
  • - In-segment total re-occlusion at 8 months; [ Time Frame: 8 month ]
  • - Target Lesion Revascularization (TLR) at 8 ,12 and 24 months; [ Time Frame: two years ]
  • - Target Vessel Revascularization (TVR) at 8 ,12 and 24 months; [ Time Frame: two years ]
  • - Angiographic success defined as achievement of a final residual diameter stenosis of < 30 % (by QCA)using the assigned study stent; [ Time Frame: procedure date ]
  • - 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; [ Time Frame: procedure date ]
  • - 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; [ Time Frame: one month ]
  • - 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. [ Time Frame: two yeras ]


Original Secondary Outcome:

  • - Major adverse cardiac events (MACE) rate at 30 days, 8, 12 and 24 months;
  • - In-segment late loss (LL) at 8 months;
  • - 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;
  • - In-segment total re-occlusion at 8 months;
  • - Target Lesion Revascularization (TLR) at 8 ,12 and 24 months;
  • - Target Vessel Revascularization (TVR) at 8 ,12 and 24 months;
  • - Angiographic success defined as achievement of a final residual diameter stenosis of < 30 % (by QCA)using the assigned study stent;
  • - 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;
  • - 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;
  • - 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.


Information By: Società Italiana di Cardiologia Invasiva

Dates:
Date Received: September 14, 2005
Date Started: May 2005
Date Completion: February 2010
Last Updated: December 3, 2009
Last Verified: May 2009