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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Società Italiana di Cardiologia Invasiva.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Cordis Italy a division of Johnson & Johnson Medical SpA
Information provided by:
Società Italiana di Cardiologia Invasiva
ClinicalTrials.gov Identifier:
NCT00220558
First received: September 14, 2005
Last updated: December 3, 2009
Last verified: May 2009
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
Device: Coronary placement of bare metal stent vs. drug eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by Società Italiana di Cardiologia Invasiva:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Major adverse cardiac events (MACE) rate at 30 days, 8, 12 and 24 months; [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • - In-segment late loss (LL) at 8 months; [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • - 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 ] [ Designated as safety issue: No ]
  • - In-segment total re-occlusion at 8 months; [ Time Frame: 8 month ] [ Designated as safety issue: No ]
  • - Target Lesion Revascularization (TLR) at 8 ,12 and 24 months; [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • - Target Vessel Revascularization (TVR) at 8 ,12 and 24 months; [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • - Angiographic success defined as achievement of a final residual diameter stenosis of < 30 % (by QCA)using the assigned study stent; [ Time Frame: procedure date ] [ Designated as safety issue: No ]
  • - 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 ] [ Designated as safety issue: No ]
  • - 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 ] [ Designated as safety issue: Yes ]
  • - 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 ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: May 2005
Estimated Study Completion Date: February 2010
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220558

Locations
Italy
Ospedale San Donato
Arezzo, Italy, 52100
Cliniche Gavazzeni
Bergamo, Italy
Ospedale Sant'Orsola-Malpighi
Bologna, Italy, 40138
Ospedale Vittorio Emanuele
Catania, Italy, 95124
Ospedale Sant'Anna
Como, Italy, 22100
Azienda Ospedaliera Villa Scassi
Genoa, Italy, 16149
Ospedale San Martino
Genova, Italy, 16132
Ospedale Civile di Legnano
Legnano, Italy, 20025
Ospedale Civile di Mestre
Mestre, Italy, 30174
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Azienda Ospedaliera Pisana
Pisa, Italy, 56127
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy, 42100
Ospedale San Giovanni Battista Università
Torino, Italy, 10143
Ospedale Cà Foncello
Treviso, Italy, 31100
Sponsors and Collaborators
Società Italiana di Cardiologia Invasiva
Cordis Italy a division of Johnson & Johnson Medical SpA
Investigators
Principal Investigator: Paolo Rubartelli, MD Azienda Ospedaliera Villa Scassi - Genoa - Italy
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Paolo Rubartelli, Ospedale Villascassi, Genova Italy
ClinicalTrials.gov Identifier: NCT00220558     History of Changes
Other Study ID Numbers: CRDIT 00-01/04
Study First Received: September 14, 2005
Last Updated: December 3, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by Società Italiana di Cardiologia Invasiva:
Percutaneous Transluminal Coronary Angioplasty
Bare metal stents
drug eluting stents

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Coronary Occlusion
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014