Full Text View
Tabular View
No Study Results Posted
Related Studies
GISSOC II: Sirolimus Eluting Stent Versus Bare Metal Stent in Chronic Total Coronary Occlusions
This study is currently recruiting participants.
Verified by Società Italiana di Cardiologia Invasiva, September 2005
First Received: September 14, 2005   Last Updated: September 15, 2005   History of Changes
Sponsors and Collaborators: Società Italiana di Cardiologia Invasiva
Cordis Italy a division of Johnson & Johnson Medical SpA
Information provided by: Società Italiana di Cardiologia Invasiva
ClinicalTrials.gov Identifier: NCT00220558
  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 or drug eluting stent
Phase IV

MedlinePlus related topics: Coronary Artery Disease
Drug Information available for: Sirolimus
U.S. FDA Resources
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.

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).

Secondary Outcome Measures:
  • - 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.

Estimated Enrollment: 200
Study Start Date: May 2005
Estimated Study Completion Date: May 2008
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 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.

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

Contacts
Contact: Monica Repetto, MD +39-02-34938362 repetto@mcr-med.com

Locations
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            
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:
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

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

Study placed in the following topic categories:
Sirolimus
Arterial Occlusive Diseases
Coronary Occlusion
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

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

ClinicalTrials.gov processed this record on May 06, 2009