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Sponsors and Collaborators: |
Società Italiana di Cardiologia Invasiva Cordis Italy a division of Johnson & Johnson Medical SpA |
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Information provided by: | Società Italiana di Cardiologia Invasiva |
ClinicalTrials.gov Identifier: | NCT00220558 |
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 |
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Coronary Artery Disease |
Device: Coronary placement of bare metal stent or drug eluting stent |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 200 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | May 2008 |
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 200 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Monica Repetto, MD | +39-02-34938362 | repetto@mcr-med.com |
Italy | |
Azienda Ospedaliera Villa Scassi | Recruiting |
Genoa, Italy, 16149 | |
Contact: Paolo Rubartelli, MD +39-010-4102488 paolo.rubartelli@villascassi.it | |
Principal Investigator: Paolo Rubartelli, MD | |
Ospedale Cà Foncello | Recruiting |
Treviso, Italy, 31100 | |
Contact: Zoran Olivari, MD | |
Principal Investigator: Zoran Olivari, MD | |
Istituti Ospitalieri di Verona | Not yet recruiting |
Verona, Italy, 37126 | |
Contact: Corrado Vassanelli, MD | |
Principal Investigator: Corrado Vassanelli, MD | |
Ospedale Vittorio Emanuele | Not yet recruiting |
Catania, Italy, 95124 | |
Contact: Corrado Tamburino, MD | |
Principal Investigator: Corrado Tamburino, MD | |
Ospedale Civile di Legnano | Not yet recruiting |
Legnano, Italy, 20025 | |
Contact: Stefano De Servi, MD | |
Principal Investigator: Stefano De Servi, MD | |
Azienda Ospedaliera di Padova | Not yet recruiting |
Padova, Italy, 35128 | |
Contact: Angelo Ramondo, MD | |
Principal Investigator: Angelo Ramondo, MD | |
Ospedale Sant'Orsola-Malpighi | Not yet recruiting |
Bologna, Italy, 40138 | |
Contact: Antonio Marzocchi, MD | |
Principal Investigator: Antonio Marzocchi, MD | |
Ospedale San Donato | Recruiting |
Arezzo, Italy, 52100 | |
Contact: Leonardo Bolognese, MD | |
Principal Investigator: Leonardo Bolognese, MD | |
Azienda Ospedaliera Pisana | Not yet recruiting |
Pisa, Italy, 56127 | |
Contact: Anna Sonia Petronio, MD | |
Principal Investigator: Anna Sonia Petronio, MD | |
Policlinico Mater Domini | Not yet recruiting |
Catanzaro, Italy, 88100 | |
Contact: Ciro Indolfi, MD | |
Principal Investigator: Ciro Indolfi, MD | |
Policlinico Umberto I | Not yet recruiting |
Roma, Italy, 00161 | |
Contact: Gennaro Sardella, MD | |
Principal Investigator: Gennaro Sardella, MD | |
Ospedale Sant'Anna | Not yet recruiting |
Como, Italy, 22100 | |
Contact: Santino Zerboni, MD | |
Principal Investigator: Santino Zerboni, MD | |
Ospedale Civile di Mestre | Not yet recruiting |
Mestre, Italy, 30174 | |
Contact: Francesco Di Pede, MD | |
Principal Investigator: Francesco Di Pede, MD | |
Arcispedale Santa Maria Nuova | Recruiting |
Reggio Emilia, Italy, 42100 | |
Contact: Antonio Manari, MD | |
Principal Investigator: Antonio Manari, MD | |
Ospedali Riuniti San Giovanni di Dio e Ruggi D'Aragona | Not yet recruiting |
Salerno, Italy, 84131 | |
Contact: Pietro Giudice, MD | |
Principal Investigator: Pietro Giudice, MD | |
Ospedale San Martino | Recruiting |
Genova, Italy, 16132 | |
Contact: Massimo Vischi, MD | |
Principal Investigator: Massimo Vischi, MD | |
Ospedale San Bortolo | Not yet recruiting |
Vicenza, Italy, 36100 | |
Contact: Alessandro Fontanelli, MD | |
Principal Investigator: Alessandro Fontanelli, MD | |
Azienda Ospedaliera Treviglio | Not yet recruiting |
Treviglio, Italy, 24047 | |
Contact: Antonio Pitì, MD | |
Principal Investigator: Antonio Pitì, MD | |
Ospedali Riuniti di Trieste | Not yet recruiting |
Trieste, Italy, 34125 | |
Contact: Alessandro Salvi, MD | |
Principal Investigator: Alessandro Salvi, MD | |
Ospedale di Cittadella | Not yet recruiting |
Cittadella, Italy, 35013 | |
Contact: Mario Zanchetta, MD | |
Principal Investigator: Mario Zanchetta, MD | |
Ospedale San Giovanni Battista | Not yet recruiting |
Torino, Italy, 10143 | |
Contact: Sebastiano Marra, MD | |
Principal Investigator: Sebastiano Marra, MD | |
Policlinico Federico II | Not yet recruiting |
Napoli, Italy, 80131 | |
Contact: Federico Piscione, MD | |
Principal Investigator: Federico Piscione, MD |
Principal Investigator: | Paolo Rubartelli, MD | Azienda Ospedaliera Villa Scassi - Genoa - Italy |
Study ID Numbers: | CRDIT 00-01/04 |
Study First Received: | September 14, 2005 |
Last Updated: | September 15, 2005 |
ClinicalTrials.gov Identifier: | NCT00220558 History of Changes |
Health Authority: | Italy: Ministry of Health |
Percutaneous Transluminal Coronary Angioplasty Bare metal stents drug eluting stents |
Sirolimus Arterial Occlusive Diseases Coronary Occlusion Coronary Disease Heart Diseases |
Myocardial Ischemia Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Occlusion Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |