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

Coronary Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00220558
• Other study ID #: CRDIT 00-01/04
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: December 3, 2009
• Start date: May 2005
• Est. completion date: February 2010

Study information

• Verified date: May 2009
• Source: Società Italiana di Cardiologia Invasiva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: February 2010
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Occlusion
• Myocardial Ischemia

Intervention

Device:
• Coronary placement of bare metal stent vs. drug eluting stent

Locations

Country	Name	City	State
Italy	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	Padova
Italy	Azienda Ospedaliera Pisana	Pisa
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia
Italy	Ospedale San Giovanni Battista Università	Torino
Italy	Ospedale Cà Foncello	Treviso

Sponsors (2)

Lead Sponsor	Collaborator
Società Italiana di Cardiologia Invasiva	Cordis Italy a division of Johnson & Johnson Medical SpA

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		8 month	No
Secondary	- Major adverse cardiac events (MACE) rate at 30 days, 8, 12 and 24 months;		two years	Yes
Secondary	- In-segment late loss (LL) at 8 months;		8 months	No
Secondary	- 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;		eight month	No
Secondary	- In-segment total re-occlusion at 8 months;		8 month	No
Secondary	- Target Lesion Revascularization (TLR) at 8 ,12 and 24 months;		two years	Yes
Secondary	- Target Vessel Revascularization (TVR) at 8 ,12 and 24 months;		two years	Yes
Secondary	- Angiographic success defined as achievement of a final residual diameter stenosis of < 30 % (by QCA)using the assigned study stent;		procedure date	No
Secondary	- 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;		procedure date	No
Secondary	- 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;		one month	Yes
Secondary	- 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.		two yeras	Yes

External Links

•   Società Italiana di Cardiologia Invasiva