Acrobat Coronary Stent System Effectiveness European Study (ACES)

Svelte Medical Systems

Status

Terminated

Conditions

Coronary Artery Disease

Treatments

Device: PCI with other BMS

Device: PCI with Svelte Acrobat

Study type

Interventional

Funder types

Industry

Identifiers

NCT01761591

Svelte_13-002

ID RCB: 2012-A00670-43 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

The evaluated stent is clinically non-inferior to control BMS in terms of freedom of MACE
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,
The evaluated stent does not result in more frequent adverse events than control BMS,
The evaluated stent improves direct stenting success while not decreasing procedural success compared to control BMS.
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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
All target lesions for stenting in single or multi-vessel disease meet all inclusion criteria
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