Clinical trial NCT00917163: SERIES III RUN-IN Clinical Trial: A Comparison of the Supralimus® Stent With the Xience V™ Stent
Official title: A Randomized Comparison of the Supralimus® Stent With the Xience V™ Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
restenosis
stent thrombosis
coronary stents
angioplasty
drug eluting stents
Lead sponsor: Sahajanand Medical Technologies Limited
Sponsor class: INDUSTRY
Collaborators: name: Cardialysis BV
First posted: 2009-06-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of Series III Run-In Trial is to compare the performance and efficacy of the Supralimus® sirolimus-eluting stent with the Xience V™ everolimus-eluting stent with respect to in-stent luminal late loss at 9 months as assessed by off-line QCA. Ninety percent power to reject the null hypothesis that the Supralimus® stent is inferior to Xience V™ in favor of the alternative hypothesis that the Supralimus® stent is not inferior to Xience V™.

Detailed description: Series III Run-In is a prospective, multi-center, randomized, single-blind (patient-blind), non-inferiority trial to be conducted at approx. 35 interventional cardiology centers in India, Brazil, Argentina, Thailand and Saudi Aurabia. A total of 360 will be randomized on a 2:1 basis to either the Supralimus® (sirolimus-eluting) stent or the Xience V™ (everolimus-eluting) stent.

In selected sites, IVUS will also be recorded in these patients (maximum of 60 IVUS patients in total), at baseline (post-procedure) and at 9-month follow-up.

All patients will be followed clinically for up to 5 years after stent implantation. Repeat angiography will be performed in all patients at 9 months after the index procedure.

Eligibility criteria: Inclusion criteria:

1. Age ≥18 years.
2. Eligible for percutaneous coronary intervention (PCI)
3. Acceptable candidate for CABG
4. Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C or IIIB-C), or documented silent ischemia.
5. The target lesion is a single de novo coronary artery lesion with ≥ 50% and \< 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with the inclusion/exclusion criteria and will receive the same type of stent.
6. The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
7. The target lesion must be ≤ 22 mm in length by visual estimate.
8. The target reference vessel diameter must be ≥ 2.5 mm and ≤ 3.5 mm.
9. Patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the clinical site.

Exclusion Criteria:

1. Female of childbearing potential
2. Documented left ventricular ejection fraction (LVEF) ≤ 30%
3. Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure
4. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, sirolimus, everolimus, stainless steel, cobalt, chromium, contrast agent (that cannot be adequately pre-medicated)
5. A platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a WBC \<3,000 cells/mm3
6. Acute or chronic renal dysfunction (creatinine \>2.0mg/dl or \>150µmol/L)
7. Total occlusion (TIMI 0) or TIMI 1
8. Target vessel has evidence of thrombus
9. Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment
10. Previous bare metal stenting (less than 1 year) anywhere within the target vessel
11. Previous drug-eluting stenting anywhere within any epicardial vessel
12. The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
13. Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off
14. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated
15. Target lesion is located in or supplied by an arterial or venous bypass graft
16. Ostial target lesion
17. Target lesion involves a side branch \>2.0mm in diameter with an ostial disease
18. Patient is currently participating in an investigational drug or device study, including its follow-up period
19. Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind
20. Within 60 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed.
21. Stroke or transient ischemic attack within the prior 6 months
22. Unprotected Left Main (LM) coronary artery disease (stenosis \>50%)
23. In the investigator's opinion, patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
24. Planned surgery within 6 months after the index procedure
25. Life expectancy less than 1 year

Primary outcomes:
measure: In-stent luminal late loss at 9 months after stent implantation (off-line QCA).
timeFrame: 9 months
Secondary outcomes:
measure: PROCEDURAL: Pre-procedure Syntax Score (by off-line visual assessment), Procedural success rate, Device success rate
timeFrame: Hospital discharge
measure: ANGIOGRAPHIC : Minimal lumen diameter (MLD), % diameter stenosis, In-segment late loss, Proximal late loss, Distal late loss, Binary restenosis rate
timeFrame: 9 months
measure: IVUS (in a subset of patients): Minimal lumen area, Vessel volume, Lumen volume, Neointimal hyperplasia, Volume obstruction, Incomplete stent apposition, Plaque behind the stent struts
timeFrame: 9 months
measure: DEVICE-ORIENTED COMPOSITE ENDPOINT : Cardiac death, MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR)
timeFrame: 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years
measure: PATIENT-ORIENTED COMPOSITE ENDPOINT : All-cause death, Any MI (including non-target vessel territory), Any repeat revascularization (including all target and non-target vessel)
timeFrame: 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years
measure: STENT THROMBOSIS
timeFrame: 30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years
Other outcomes:
Locations:
city: Vitaria
country: Brazil
facility: Hospital Meridional
state: Espirito Santo
city: Goiania
country: Brazil
facility: Centro de Cardiologia e Radiologia Intervencionista
state: Goiás.
city: Campo Grande
country: Brazil
facility: Cardiovascular Diagnóstico
state: Mato Grosso do Sul
city: Juiz de Fora
country: Brazil
facility: Santa Casa de misericórdia de Juiz de fora
state: Minas Gerais
city: Uberlandia
country: Brazil
facility: Intistuto do Coracao do Triangulo
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Hospital Costantino Constantini
state: Paraná
city: Brasília
country: Brazil
facility: Incor Hospital
city: Sao Paulo
country: Brazil
facility: Instituto de Cardiologia
city: Sao Paulo
country: Brazil
facility: Hospital Bandeirantes
city: Sao Paulo
country: Brazil
facility: Incor Hospital
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese
city: Sao Paulo
country: Brazil
facility: Hospital Albert Einstein
city: Sao Paulo
country: Brazil
facility: Hospital Santa Marcelina
city: New Delhi
country: India
facility: Escorts Heart Institute & Research Centre
state: Delhi
city: New Delhi
country: India
facility: Max Devki Devi Heart and Vascular Institute
state: Delhi
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: Ahmedabad
country: India
facility: Life Care Institute
state: Gujarat
city: Bangalore
country: India
facility: Shri.Jayadeva Institute of Cardiology
state: Karnataka
city: Trivandrum
country: India
facility: P.R.S Hospital
state: Kerala
city: Mumbai
country: India
facility: Jaslok Hospital & Research Centre
state: Maharashtra
city: Mumbai
country: India
facility: KEM Hospital
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Chennai
country: India
facility: Madras Medical Mission
state: Tamil Nadu
city: Chennai
country: India
facility: Apollo Hospital
state: Tamilnadu
city: Lucknow
country: India
facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences
state: Uttar Pradesh
city: Noida
country: India
facility: Kailash Health Care Limited
state: Uttar Pradesh
city: Kolkata
country: India
facility: B.M.Birla Heart Research Center
state: West Bengal
city: Jeddah
country: Saudi Arabia
facility: KAUH King Abdl Aziz University Hospital
Study officials:
affiliation: Thoraxcenter,Rotterdam,NL
name: Prof. Patrick W Serruys, MD, Ph.D
role: STUDY_CHAIR
References:
citation: Dani S, Kukreja N, Parikh P, Joshi H, Prajapati J, Jain S, Thanvi S, Shah B, Dutta JP. Biodegradable-polymer-based, sirolimus-eluting Supralimus stent: 6-month angiographic and 30-month clinical follow-up results from the series I prospective study. EuroIntervention. 2008 May;4(1):59-63. doi: 10.4244/eijv4i1a11.
citation: Dr. A.Abhyankar; Evaluation of Safety, Efficacy and Procedural Outcomes of Extra Long Sirolimus Eluting Stent with novel polymeric technology for treatment of long de novo coronary lesions; Catheterization Cardiovascular Interventions; 3rd Nov - 2nd Dec 2006; DOI 10.1002/ccd.21033