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

NCT ID: NCT00220558

Last Updated: 2009-12-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2010-02-28

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 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.

Conditions

Coronary Artery Disease

Keywords

Percutaneous Transluminal Coronary Angioplasty; Bare metal stents; drug eluting stents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Coronary placement of bare metal stent vs. drug eluting stent

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Italy a division of Johnson & Johnson Medical SpA

UNKNOWN

Sponsor Role: collaborator

Società Italiana di Cardiologia Invasiva

OTHER

Sponsor Role: lead

Responsible Party

Ospedale Villascassi, Genova Italy

Principal Investigators

Paolo Rubartelli, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Villa Scassi - Genoa - Italy

Locations

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

Padua, , Italy

Azienda Ospedaliera Pisana

Pisa, , Italy

Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Ospedale San Giovanni Battista Università

Torino, , Italy

Ospedale Cà Foncello

Treviso, , Italy

Countries

Italy

References

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. doi: 10.1016/s0735-1097(98)00193-4.

Reference Type: BACKGROUND

PMID: 9669254 (View on PubMed)

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. doi: 10.1056/NEJMoa035071.

Reference Type: BACKGROUND

PMID: 14523139 (View on PubMed)

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. doi: 10.1016/j.jacc.2004.01.045.

Reference Type: BACKGROUND

PMID: 15172397 (View on PubMed)

Rubartelli P, Petronio AS, Guiducci V, Sganzerla P, Bolognese L, Galli M, Sheiban I, Chirillo F, Ramondo A, Bellotti S; Gruppo Italiano di Studio sullo Stent nelle Occlusioni Coronariche II GISE Investigators. Comparison of sirolimus-eluting and bare metal stent for treatment of patients with total coronary occlusions: results of the GISSOC II-GISE multicentre randomized trial. Eur Heart J. 2010 Aug;31(16):2014-20. doi: 10.1093/eurheartj/ehq199. Epub 2010 Jun 20.

Reference Type: DERIVED

PMID: 20566487 (View on PubMed)

Related Links

http://www.gise.it/

Società Italiana di Cardiologia Invasiva

Other Identifiers

CRDIT 00-01/04

Identifier Type: -

Identifier Source: org_study_id