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Coronary Artery DiseaseACESNCT01761591

Acrobat Coronary Stent System Effectiveness European Study

A study testing PCI with Svelte Acrobat and PCI with other BMS in people with Coronary Artery Disease, run by Svelte Medical Systems Europe at 12 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
PCI with Svelte Acrobat and PCI with other BMS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
12 sitesin 3 countries
Study dates
Dec 2012to Jan 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 32Show fewer
  • 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

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

France7 sites

  • CHU Nord Grenoble - A. Michalon

    La Tronche, 38700

  • AP-HP Hôpital Européen Georges Pompidou

    Paris, 75015

  • AP-HP La Pitié Salpétrière

    Paris, 75651

  • CHU Bordeaux Sud - Hôpital Cardiologique Haut Lévêque

    Pessac, 33604

  • Clinique St Hilaire

    Rouen, 76000

  • CHU Rangueil

    Toulouse, 31059

  • Clinique Pasteur

    Toulouse, 31300

Other trials in France

Belgium4 sites

  • OLV Ziekenhuis

    Aalst, B-9300

  • ZNA Middelheim - Hartcentrum

    Antwerp, B-2020

  • ZOL Sint Jan

    Genk, B-3600

  • CHU Liège - Sart Tilman

    Liège, B-4000

Other trials in Belgium

Spain1 site

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

Other trials in Spain

About this study

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

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.

Read the 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.):
  6. 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
  7. 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.
Being tested
PCI with Svelte Acrobat, PCI with other BMS
Keywords
CAD, PCI, BMS, Svelte, Acrobat, direct stenting, RCT
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCI with Svelte AcrobatDevice

    Percutaneous coronary intervention with Svelte Acrobat Coronary Stent System

  • PCI with other BMSDevice

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

Study groups in NCT01761591
Study groupRoleWhat they receive
AcrobatExperimentalDevice: PCI with Svelte Acrobat
Receives: Device: PCI with Svelte Acrobat
Control BMSActive comparatorDevice: PCI with other BMS
Receives: Device: PCI with other BMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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").

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

Secondary outcomes (6)

  1. administered dye

    Volume (ml) of administered dye i.e. injected radiological contrast medium.

    Measured: intra-procedural

  2. procedure duration

    Procedure duration (minutes) from arterial access to closure.

    Measured: intra-procedural

  3. radiation exposure

    Radiation exposure (gY/cm²) \& total fluoroscopy time (min)

    Measured: intra-procedural

  4. acute success

    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

    Measured: procedure to discharge

  5. heparin administration

    Amount of heparin administered during the procedure

    Measured: intra-procedural

  6. adverse events

    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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionJan 2014
  4. Study completionJan 2014

Why it stopped: Difficulty to identify eligible patients: 8 centers contributed 54 patients in 6 months.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01761591
Sponsor's protocol ID
Svelte_13-002
Other IDs
ID RCB: 2012-A00670-43
Acronym
ACES
Status last verified
Aug 2014
First submitted
12 Dec 2012
Last updated
26 Aug 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20357387

  • 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.

    PubMed 22865317

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing PCI with Svelte Acrobat and PCI with other BMS in people with Coronary Artery Disease, run by Svelte Medical Systems Europe at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France, Belgium, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Difficulty to identify eligible patients: 8 centers contributed 54 patients in 6 months.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01761591, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2014.

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ACES Clinical Trial NCT01761591 | AzTrials