Acrobat Coronary Stent System Effectiveness European Study

NCT01761591 | Terminated

• 2 other identifiers: Svelte_13-002ID RCB: 2012-A00670-43
• Study Type: interventional
• Target: 300
• Locations: 3 countries
• Sites: 12

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.

Conditions

Coronary Artery Disease

Keywords

CAD; PCI; BMS; Svelte; Acrobat; direct stenting; RCT

Outcome Measures

Primary Outcomes (1)

• Proportion of patients free of Major Adverse Cardiac Event ("MACE-free patients")

  Major Adverse Cardiac Event ("MACE") is defined here as device-oriented composite endpoint that includes, in hierarchical order: Cardiac death (All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established), Myocardial Infarction ("MI"), Target Lesion Revascularization ("TLR").

  From the date and time of randomization until 6 months after the index procedure

Secondary Outcomes (6)

• administered dye

  intra-procedural

• procedure duration

  intra-procedural

• radiation exposure

  intra-procedural

• acute success

  procedure to discharge

• heparin administration

  intra-procedural

Other Outcomes (1)

• resource utilization

  6 months

Study Arms (2)

Acrobat

EXPERIMENTAL

Device: PCI with Svelte Acrobat

Device: PCI with Svelte Acrobat

Control BMS

ACTIVE COMPARATOR

Device: PCI with other BMS

Device: PCI with other BMS

Interventions

PCI with Svelte Acrobat DEVICE

Percutaneous coronary intervention with Svelte Acrobat Coronary Stent System

Acrobat

PCI with other BMS 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

Control BMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Svelte Medical Systems Europe: lead

Study Sites (12)

OLV Ziekenhuis

Aalst, B-9300, Belgium

Location

ZNA Middelheim - Hartcentrum

Antwerp, B-2020, Belgium

Location

ZOL Sint Jan

Genk, B-3600, Belgium

Location

CHU Liège - Sart Tilman

Liège, B-4000, Belgium

Location

CHU Nord Grenoble - A. Michalon

La Tronche, 38700, France

Location

AP-HP Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

AP-HP La Pitié Salpétrière

Paris, 75651, France

Location

CHU Bordeaux Sud - Hôpital Cardiologique Haut Lévêque

Pessac, 33604, France

Location

Clinique St Hilaire

Rouen, 76000, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

Location

Related Publications (3)

• 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.

  PMID: 20357387 BACKGROUND

• 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.

  PMID: 22865317 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jean Fajadet, MD

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

  PRINCIPAL INVESTIGATOR

• Andrew Schut

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: January 7, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

FR (7); BE (4); ES (1)