Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System

NCT01788150 | Completed Results DMC

• 1 other identifier: IP-12-002
• Study Type: interventional
• Target: 159
• Locations: 7 countries
• Sites: 18

Brief Summary

A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent. The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Angiographic In-Stent Late Lumen Loss (LL)

  Defined as the measurements either within the stented segment or within 5 mm proximal and distal to the stent edges.

  6-months post-procedure

Secondary Outcomes (11)

• Number of Participants Clinically-driven Target Lesion Revascularization (TLR)

  1 year post-procedure

• Number of Participants Composite of Cardiac Death, MI Attributed to the Target Vessel and Clinically Driven Target Lesion Revascularization

  1 year post-procedure

• Number of Participants Composite of All-cause Mortality, Any MI and Any Revascularization, Target Vessel Revascularization or Revascularization of Non Target Vessels

  1 year post-procedure

• Number of Participants Stent Thrombosis

  1 year post-procedure

• Number of Participants Acute Success Rates

  From index procedure to hospital discharge, an average of 24 hours

Study Arms (2)

Svelte Drug-Eluting Coronary Stent

EXPERIMENTAL

Coronary Stenting

Device: Coronary Stenting

Medtronic Resolute Integrity Drug-Eluting Stent

ACTIVE COMPARATOR

Coronary Stenting

Device: Coronary Stenting

Interventions

Coronary Stenting DEVICE

Medtronic Resolute Integrity Drug-Eluting Stent; Svelte Drug-Eluting Coronary Stent

Eligibility Criteria

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

You may qualify if:

• Patient is ≥18 years old;
• Patient is eligible for percutaneous coronary intervention (PCI);
• Patient is an acceptable candidate for emergent coronary artery bypass graft (CABG) surgery;
• Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study;
• Female subjects of childbearing potential must have a negative pregnancy test within 7-days before the trial procedure;
• Patient or subject's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Hospital Research Ethics Committee (HREC) of the respective investigational site; and
• Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.
• Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries;
• If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met:
• Residual diameter stenosis \< 30%;
• Absence of any angiographic complications;
• Absence of ischemic symptoms; and
• Absence of significant new arrhythmia or ECG monitoring changes suggestive of ischemia.
• Reference vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter by visual estimate;
• Target lesion \< 20 mm in length by visual estimate (the intention is to cover the entire lesion with one stent of adequate length); and

You may not qualify if:

• Patient is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials;
• The patient requires a staged procedure of the target vessel within 6-months or a staged procedure of a non-target vessel within 30-days post-procedure;
• The target lesion 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.);
• Any DES deployment anywhere in the target vessel within the past 9-months;
• Any BMS deployment anywhere in the target vessel within the past 6-months;
• Any previous stent placement within 10 mm (proximal or distal) of the target lesion;
• Myocardial infarction within 72-hours of the index procedure, with the exception of:
• Patients who have had a STEMI and PCI to the culprit lesion may be included if they have a suitable lesion in another vessel, and have been clinically and hemodynamically stable for 72-hours;
• Patients who have had a non-STEMI may be included if their troponin levels are within the laboratory normal range within 24-hours pre-procedure.
• Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial;
• Concurrent medical condition with a life expectancy of less than 12-months;
• Documented left ventricular ejection fraction (LVEF) ≤ 30%;
• Unstable angina pectoris from an extra-cardiac cause (Braunwald Class A I-III);
• Known allergies to the following: Acetylsalicylic acid (ASA), Clopidogrel bisulfate, Ticlopidine, Prasugrel, Rapamycin, Zotarolimus, PEAIII AcBz, Heparin/ Bivalirudin, or contrast agent (that cannot be adequately premedicated);
• Platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3 or a WBC \< 3.000 cells/mm3 or hemoglobin \< 100g/l;

Sponsors & Collaborators

• Svelte Medical Systems, Inc.: lead

Study Sites (18)

OLV Ziekenhuis Aalst

Aalst, Belgium

Location

Middelheim Ziekenhuis

Antwerp, Belgium

Location

ZOL Genk

Genk, Belgium

Location

CHU Liège

Liège, Belgium

Location

Všeobecná fakultní nemocnice Praha

Prague, Czechia

Location

Clinique Saint-Hilaire

Rouen, France

Location

CHU de Toulouse

Toulouse, France

Location

Clinique Pasteur

Toulouse, France

Location

Medizinisches Verzorgungszentrum Prof. Mathey, Prof. Schofer

Hamburg, Germany

Location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

OLVG Amsterdam

Amsterdam, Netherlands

Location

Catharina Hospital Eindhoven

Eindhoven, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

University Medical Center Utrecht, Department of Cardiology

Utrecht, Netherlands

Location

Skane University Hospital

Malmo, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

Inselspital

Bern, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Betsy Lowry
• Organization: Svelte Medical

blowry@sveltemedical.com

19082642181

Study Officials

• Stefan Verheye, MD, PhD

  Antwerp Cardiovascular Institute

  PRINCIPAL INVESTIGATOR

• Alexandre Abizaid, MD, PhD

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: February 5, 2013
• First Posted: February 11, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 31, 2019
• Last Updated: May 4, 2021
• Results First Posted: May 4, 2021

Record last verified: 2021-04

Locations

SE (2); NL (5); FR (3); CZ (1); BE (4); DE (2); CH (1)