Sahajanand Medical Technologies Pvt. Ltd.

Sahajanand Medical Technologies Pvt. Ltd.

Clinical Trials

CLINICAL TRIALS > SERIES III RUN-IN

Supralimus-Core™

SERIES III Run-In

Study Design

Chairman:	Prof. Patrick W Serruys
Co-Chairman:	Dr. Alexandre Abizaid
Study Title:	A randomized comparison of the Supralimus-Core™ stent with the Xience V™ stent in the treatment of patients
	with de novo native coronary artery lesions.

Objective:	To compare the performance and efficacy of the Supralimus-Core™ 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.

Design:	Prospective, multi-center, randomized, single-blind, non-inferiority trial to be conducted at several international
	interventional cardiology centers. Patients will be randomized 2:1 to the Supralimus Core™ stent or the Xience V™
	stent respectively. All patients will undergo repeat angiography at 9 months. 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 at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.

Clinical sites:	Approx. 30 interventional cardiology centers in India, Brazil, Argentina and Thailand.
Enrollment:	A total of 400 patients will be enrolled.
Randomization:	Patients will be randomized 2:1 to the Supralimus-Core™ stent or the Xience V™ stent respectively.
Status:	Awaiting regulatory approval

Study endpoints:	Primary endpoint
	In-stent luminal late loss at 9 months after stent implantation (offline QCA).

	Secondary endpoints
	Procedural:
	• Pre-procedure Syntax Score (by off-line visual assessment) • Procedural success rate • Device success rate
	Angiographic (9 months):
	• Minimal lumen diameter (MLD) • % diameter stenosis • In-segment late loss • Proximal late loss • Distal late loss • Binary restenosis rate

	IVUS (in a subset of patients) (9 months):
	• Minimal lumen area • Vessel volume • Lumen volume • Neointimal hyperplasia • Volume obstruction • Incomplete stent apposition • Plaque behind the stent struts

	Device-oriented composite endpoint (30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years):
	• Cardiac death • MI not clearly attributable to a non-target vessel • Target lesion revascularization (TLR)

	Patient-oriented composite endpoint (30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years):
	• All-cause death • Any MI (including non-target vessel territory) • Any repeat revascularization (including all target and nontarget vessel)

	Stent thrombosis (30 days, 6 months, 9 months, 1, 2, 3, 4, and 5 years)

Sahajanand Medical Technologies Pvt. Ltd. - "Sahajanand Estate", Wakhariawadi, Nr. Dabholi Char Rasta, Ved Road, Surat - 395004 (Guj.), India

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