Acrobat Coronary Stent System Effectiveness European Study (ACES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Svelte Medical Systems Europe
Information provided by (Responsible Party):
Svelte Medical Systems Europe Identifier:
First received: December 12, 2012
Last updated: April 25, 2013
Last verified: April 2013

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.

Condition Intervention
Coronary Artery Disease
Device: PCI with Svelte Acrobat
Device: PCI with other BMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acrobat Coronary Stent System Effectiveness European Study (European Multicenter Effectiveness Randomized Study of Svelte Medical Systems Acrobat Stent on a Wire Compared to Other BMS PCI in de Novo Coronary Lesions) ACES Trial

Resource links provided by NLM:

Further study details as provided by Svelte Medical Systems Europe:

Primary Outcome Measures:
  • Proportion of patients free of Major Adverse Cardiac Event ("MACE-free patients") [ Time Frame: From the date and time of randomization until 6 months after the index procedure ] [ Designated as safety issue: No ]
    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").

Secondary Outcome Measures:
  • administered dye [ Time Frame: intra-procedural ] [ Designated as safety issue: No ]
    Volume (ml) of administered dye i.e. injected radiological contrast medium.

  • procedure duration [ Time Frame: intra-procedural ] [ Designated as safety issue: No ]
    Procedure duration (minutes) from arterial access to closure.

  • radiation exposure [ Time Frame: intra-procedural ] [ Designated as safety issue: No ]
    Radiation exposure (gY/cm²) & total fluoroscopy time (min)

  • acute success [ Time Frame: procedure to discharge ] [ Designated as safety issue: No ]

    Acute success is measured at procedure end according to 4 criteria:

    1. Lesion success: Residual stenosis of the target lesion < 30% of the RVD using any percutaneous method.
    2. Direct stenting success: Lesion success without unplanned pre-dilation performed (planned pre-dilation is an exclusion criterion) from the trial.
    3. Device Success: Direct stenting success without post-dilatation or with post-dilatation using the Stent Delivery System (SDS).
    4. Procedure success: Lesion success & no in-hospital MACE

  • heparin administration [ Time Frame: intra-procedural ] [ Designated as safety issue: No ]
    Amount of heparin administered during the procedure

  • adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    Adverse events occurrence:

    1. Death
    2. MI
    3. Repeat coronary revascularization
    4. Bleeding or vascular complications at discharge
    5. Stent thrombosis up to 6 months
    6. Other serious adverse events

Other Outcome Measures:
  • resource utilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Resource utilization (R.U.) endpoints:

    Overall procedural and follow-up R.U. including:

    • Man-time
    • Facility usage
    • Amount of medical devices and drugs used:

      1. during index procedure
      2. after index procedure until discharge
      3. between discharge and 6-month follow-up

Estimated Enrollment: 300
Study Start Date: December 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acrobat
Device: PCI with Svelte Acrobat
Device: PCI with Svelte Acrobat
Percutaneous coronary intervention with Svelte Acrobat Coronary Stent System
Active Comparator: Control BMS
Device: PCI with other BMS
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

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01761591

Contact: Andrew Schut +1.908.264.2181
Contact: Jean de Schepper +32 (0)2 517 6012

OLV Ziekenhuis Recruiting
Aalst, Belgium, B-9300
Contact: Jozef Bartounek, MD         
Principal Investigator: Jozef Bartounek, MD         
ZNA Middelheim - Hartcentrum Recruiting
Antwerpen, Belgium, B-2020
Contact: Stefan Verheye, MD         
Principal Investigator: Stefan Verheye, MD         
ZOL Sint Jan Recruiting
Genk, Belgium, B-3600
Contact: Mathias Vrolix, MD         
Principal Investigator: Mathias Vrolix, MD         
CHU Liège - Sart Tilman Recruiting
Liège, Belgium, B-4000
Contact: Victor Legrand, MD         
Principal Investigator: Victor Legrand, MD         
CHU Nord Grenoble - A. Michalon Recruiting
La Tronche, France, 38700
Contact: Bernard Bertrand         
Principal Investigator: Bernard Bertrand, MD         
AP-HP La Pitié Salpétrière Recruiting
Paris, France, 75651
Contact: Gilles Montalescot, MD         
Principal Investigator: Gilles Montalescot, MD         
AP-HP Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Christian Spaulding, MD         
Principal Investigator: Christian Spaulding, MD         
CHU Bordeaux Sud - Hôpital Cardiologique Haut Lévêque Recruiting
Pessac, France, 33604
Contact: Pierre Coste, MD         
Principal Investigator: Pierre Coste, MD         
Clinique St Hilaire Recruiting
Rouen, France, 76000
Contact: Jacques Berland, MD         
Principal Investigator: Jacques Berland, MD         
Clinique Pasteur Recruiting
Toulouse, France, 31300
Contact: Jean Fajadet, MD         
Principal Investigator: Jean Fajadet, MD         
CHU Rangueil Recruiting
Toulouse, France, 31059
Contact: Didier Carrié, MD         
Principal Investigator: Didier Carrié, MD         
Hospital Universitari Vall d'Hebrón Recruiting
Barcelona, Spain, 08035
Contact: Bruno García del Blanco, MD         
Principal Investigator: Bruno García del Blanco, MD         
Sponsors and Collaborators
Svelte Medical Systems Europe
Principal Investigator: Jean Fajadet, MD Clinique Pasteur, 45 avenue Lombez, Toulouse 31300, France, Tel. 33 (0)5 62 21 16 99 -
Study Director: Andrew Schut Svelte Medical Systems, Inc., 675 Central Avenue, New Providence, NJ 07974, USA, Tel. 1.908.264.2181 -
  More Information

Additional Information:
Responsible Party: Svelte Medical Systems Europe Identifier: NCT01761591     History of Changes
Other Study ID Numbers: Svelte_13-002, ID RCB: 2012-A00670-43
Study First Received: December 12, 2012
Last Updated: April 25, 2013
Health Authority: France: Institutional Ethical Committee
Belgium: Ethics Committee
Spain: Comité Ético de Investigación Clínica

Keywords provided by Svelte Medical Systems Europe:
direct stenting

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on August 01, 2014