Acrobat Coronary Stent System Effectiveness European Study

NCT ID: NCT01761591

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-01-31

Brief Summary

The purpose of this randomized controlled trial (RCT) is to demonstrate the clinical benefit and impact on resource utilization of percutaneous coronary interventions (PCI) with the Svelte Acrobat Stent System compared to any other CE marked bare metal stent (BMS) implantable via direct stenting or after lesion pre-dilation, in patients with coronary lesions that are eligible for direct stenting and who are recruited and treated so as to reflect real-life routine practice.

Detailed Description

The main objectives of this study are to test the following hypotheses:

1. The evaluated stent is clinically non-inferior to control BMS in terms of freedom of MACE

2. The evaluated stent is clinically beneficial compared to control BMS by reducing exposure to radiations, amount of contrast medium administered, procedure time, as well as amount of administered heparin,

3. The evaluated stent does not result in more frequent adverse events than control BMS,

4. The evaluated stent improves direct stenting success while not decreasing procedural success compared to control BMS.

5. Resource utilization (R.U.):

1. Hospital-perspective resource utilization during the index admission and index procedure is not greater with evaluated the stent and potentially lower than with control BMS

2. Resource utilization over a 6-month time-horizon, in relation to routine follow-up and MACE, is not greater with the evaluated stent than with control BMS.

Conditions

Coronary Artery Disease

Study Design

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

Study Groups

Acrobat

Device: PCI with Svelte Acrobat

Group Type: EXPERIMENTAL

PCI with Svelte Acrobat

Intervention Type: DEVICE

Percutaneous coronary intervention with Svelte Acrobat Coronary Stent System

Control BMS

Device: PCI with other BMS

Group Type: ACTIVE_COMPARATOR

PCI with other BMS

Intervention Type: DEVICE

Percutaneous coronary intervention with any other routine use CE marked bare metal stent (BMS) implantable either via direct stenting or after lesion pre-dilation

Interventions

PCI with Svelte Acrobat

Percutaneous coronary intervention with Svelte Acrobat Coronary Stent System

Intervention Type: DEVICE

PCI with other BMS

Percutaneous coronary intervention with any other routine use CE marked bare metal stent (BMS) implantable either via direct stenting or after lesion pre-dilation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Eligible for PCI and demonstrating native vessel or vein/arterial graft disease
• symptomatic CAD: either stable angina pectoris (CCS 1, 2, 3 pr 4) or unstable (Braunwald Class 1-3, B-C) or positive functional ischemia study
• Male and post-menopausal female
• Patient provides written informed consent prior to procedure
• Patient willing to comply with protocol
• Acceptable candidate for CABG
• Patient indicated for stenting of one or more de novo stenotic lesions in native coronary arteries or bypass grafts with or without direct stenting
• None of the lesions requires stenting with Drug eluting stents
• At least one lesion is visually estimated to be candidate for direct stenting
• All target lesions for stenting have a visually estimatd RVD >= 2.5 mm and <= 3.5 mm
• All target lesions for stenting are visually estimated to have LL =< 20 mm (to cover the lesion with 1 stent)
• All target lesions for stenting visually estimated to have a stenosis > 50% and < 99%
• All target lesions for stenting are ACS lesions TIMI flow >= 1

Exclusion Criteria

• Currently enrolled in another clinical trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
• A previous coronary procedure within 30 days
• Any of the target lesion(s) requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
• Previous BMS deployment anywhere in the target vessel within the past 6 months
• Any DES deployment anywhere in the target vessel within the past 9 months
• Any previous stent placement within 10 mm (proximal or distal) of the target lesion
• Patient has diabetes mellitus
• Co-morbid condition(s) that could limit the patient's participation or impact the trial
• Documented LVEF < 30% at the most recent evaluation
• Evidence of AMI within 72 hours of the intended trial procedure and/or with TIMI flow 0
• History of CVA or TIA in the last 6 months
• Leukopenia (<3.5 x 10^9/L)
• Neutropenia (<1000/mm3) <= 3 days prior to enrollment
• Thrombocytopenia (<10^5/mm3) pre-procedure
• Active peptic ulcer or active GI bleeding
• History of bleeding diathesis or coagulopathy or inability to accept blood transfusions
• Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated
• Serum creatinine level > 2.5 mg per dl within 7 days prior to index procedure
• In-stent restenosis
• Patient not able to give consent or read or write or protected by law or under guardianship or deprived of civil rights
• Woman of childbearing age
• Patient not covered by health or social insurance
• Unprotected left main CAD with obstruction > 50% , not protected by at least one non-obstructed bypass graft to the LAD or left circumflex (LCX) artery or their branches
• Target vessel exhibiting multiple lesions > 40% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion(s) to be stented based on visual estimate or on-line QCA
• Any target lesion for stenting exhibits an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time
• Any target lesion for stenting is excessively tortuous (two bends > 90° to reach the target lesion)
• Lesion location that is aorto-ostial or within 5 mm of the origin of the LAD or LCX
• Any target lesion for stenting is has side branches > 2.0 mm in diameter in which bifurcation stenting is planned
• Any target lesion >20 mm
• Any target lesion totally occluded (CTO)
• Any target lesion has TIMI flow = 0
• Any target lesion with ISR

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

Sponsors

Svelte Medical Systems Europe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Fajadet, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Pasteur, 45 avenue Lombez, Toulouse 31300, France, Tel. 33 (0)5 62 21 16 99 - secretariat@interv-cardio-toul.com

Andrew Schut

Role: STUDY_DIRECTOR

Svelte Medical Systems, Inc., 675 Central Avenue, New Providence, NJ 07974, USA, Tel. 1.908.264.2181 - aschut@sveltemedical.com

Locations

OLV Ziekenhuis

Aalst, , Belgium

ZNA Middelheim - Hartcentrum

Antwerp, , Belgium

ZOL Sint Jan

Genk, , Belgium

CHU Liège - Sart Tilman

Liège, , Belgium

CHU Nord Grenoble - A. Michalon

La Tronche, , France

AP-HP Hôpital Européen Georges Pompidou

Paris, , France

AP-HP La Pitié Salpétrière

Paris, , France

CHU Bordeaux Sud - Hôpital Cardiologique Haut Lévêque

Pessac, , France

Clinique St Hilaire

Rouen, , France

CHU Rangueil

Toulouse, , France

Clinique Pasteur

Toulouse, , France

Hospital Universitari Vall d'Hebrón

Barcelona, , Spain

Countries

Belgium; France; Spain

References

Piscione F, Piccolo R, Cassese S, Galasso G, D'Andrea C, De Rosa R, Chiariello M. Is direct stenting superior to stenting with predilation in patients treated with percutaneous coronary intervention? Results from a meta-analysis of 24 randomised controlled trials. Heart. 2010 Apr;96(8):588-94. doi: 10.1136/hrt.2009.183277.

Reference Type: BACKGROUND

PMID: 20357387 (View on PubMed)

Shao C, Stella PR, Agostoni P. Complex made easy: left anterior descending artery trifurcation lesion completely treated with a single device. J Invasive Cardiol. 2012 Aug;24(8):E164-6.

Reference Type: BACKGROUND

PMID: 22865317 (View on PubMed)

de Ribamar Costa J, Abizaid A, Stella P, Fernandez A, Granada J, Feres F, Serruys P. Preliminary results of the svelte trial: first-in-man assessment of the novel acrobat™ SOAW (Stent-On-A-Wire) coronary system. J Am Coll Cardiol. 2011;57(14s1):E1658-E1658. doi:10.1016/S0735-1097(11)61658-6

Reference Type: BACKGROUND

Other Identifiers

ID RCB: 2012-A00670-43

Identifier Type: OTHER

Identifier Source: secondary_id

Svelte_13-002

Identifier Type: -

Identifier Source: org_study_id