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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Coronary Stenting

• Registration Number: NCT01788150
• Lead Sponsor: Svelte Medical Systems, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Primary Completion: 2014-05
• Study Completion: 2019-05-31
• Results First Submitted: 2021-03-16
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-09
• Last Update Submitted: 2021-04-09
• Results First Posted: 2021-05-04
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

General Inclusion Criteria

1. Patient is ≥18 years old;
2. Patient is eligible for percutaneous coronary intervention (PCI);
3. Patient is an acceptable candidate for emergent coronary artery bypass graft (CABG) surgery;
4. Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study;
5. Female subjects of childbearing potential must have a negative pregnancy test within 7-days before the trial procedure;
6. 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
7. Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.

Angiographic Inclusion Criteria

1. Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries;

2. 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:

   1. Residual diameter stenosis < 30%;
   2. Absence of any angiographic complications;
   3. Absence of ischemic symptoms; and
   4. Absence of significant new arrhythmia or ECG monitoring changes suggestive of ischemia.

3. Reference vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter by visual estimate;

4. Target lesion < 20 mm in length by visual estimate (the intention is to cover the entire lesion with one stent of adequate length); and

5. Target lesion stenosis ≥ 50% and < 100% by visual estimate.

Exclusion Criteria

General Exclusion Criteria

1. 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;

2. 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;

3. 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.);

4. Any DES deployment anywhere in the target vessel within the past 9-months;

5. Any BMS deployment anywhere in the target vessel within the past 6-months;

6. Any previous stent placement within 10 mm (proximal or distal) of the target lesion;

7. Myocardial infarction within 72-hours of the index procedure, with the exception of:

   1. 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;
   2. 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.

8. 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;

9. Concurrent medical condition with a life expectancy of less than 12-months;

10. Documented left ventricular ejection fraction (LVEF) ≤ 30%;

11. Unstable angina pectoris from an extra-cardiac cause (Braunwald Class A I-III);

12. 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);

13. Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3.000 cells/mm3 or hemoglobin < 100g/l;

14. Acute or chronic renal dysfunction (serum creatinine > 170μmol/L);

15. History of a stroke or transient ischemic attack (TIA) within the prior 6-months;

16. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6-months;

17. History of bleeding diathesis or coagulopathy or will refuse blood transfusions; and

18. Patients requiring ongoing anticoagulation with warfarin or dabigatran.

Angiographic Exclusion Criteria

1. Total occlusion (TIMI 0 or 1);
2. Target vessel has angiographic evidence of thrombus
3. Target vessel is excessively tortuous or has heavy calcification;
4. Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
5. Target lesion is located in or supplied by an arterial or venous bypass graft;
6. Ostial target lesion (within 5.0 mm of vessel origin) or any location within the left main coronary artery;
7. Target lesion involves a side branch > 2.0 mm in diameter; and
8. Unprotected Left Main coronary disease (stenosis > 50%).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medtronic Resolute Integrity Drug-Eluting Stent	Coronary Stenting	Coronary Stenting
Svelte Drug-Eluting Coronary Stent	Coronary Stenting	Coronary Stenting

Primary Outcome Measures

Name	Time	Method
Angiographic In-Stent Late Lumen Loss (LL)	6-months post-procedure	Defined as the measurements either within the stented segment or within 5 mm proximal and distal to the stent edges.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Target Vessel Failure	1 year post procedure	Composite endpoint of cardiac death, target vessel MI (Q or Non-Q wave), or clinically- driven target vessel revascularization (TVR) by percutaneous or surgical methods.
Number of Participants Clinically-driven Target Lesion Revascularization (TLR)	1 year post-procedure	Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as unstable angina, that is, chest pain that increases in frequency, intensity or duration.
Number of Participants Acute Success Rates	From index procedure to hospital discharge, an average of 24 hours	Direct Stenting Success, Lesion Success, Procedure Success and Device Failure
Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate	6-months post-procedure	The rate which restenosis occurs
Strut Coverage	6-months post procedure	(% of struts malapposed, protruding non-covered, protruding covered, non-protruding covered)
Number of Participants Composite of Cardiac Death, MI Attributed to the Target Vessel and Clinically Driven Target Lesion Revascularization	1 year post-procedure	Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization
Number of Participants Stent Thrombosis	1 year post-procedure	The sudden occlusion of a stented coronary artery due to thrombus formation.
In-stent and In-segment Minimum Lumen Diameter	6-months post-procedure	Smallest diameter in the stent or segment area
In-segment Late Lumen Loss	6-months post-procedure	Late lumen loss is the difference in millimeters between the diameter of a stented segment post-procedure compared with the follow-up angiogram
Neointimal Hyperplasia as Measured by OCT	6-months post procedures	(% lumen volume)
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	Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of non target vessels

Trial Locations

Locations (18)

ZOL Genk; 🇧🇪 Genk, Belgium

Inselspital; 🇨🇭 Bern, Switzerland

OLV Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

Middelheim Ziekenhuis; 🇧🇪 Antwerpen, Belgium

Clinique Pasteur; 🇫🇷 Toulouse, France

CHU Liège; 🇧🇪 Liege, Belgium

Všeobecná fakultní nemocnice Praha; 🇨🇿 Prague, Czechia

CHU de Toulouse; 🇫🇷 Toulouse, France

Medizinisches Verzorgungszentrum Prof. Mathey, Prof. Schofer; 🇩🇪 Hamburg, Germany

Clinique Saint-Hilaire; 🇫🇷 Rouen, France

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

OLVG Amsterdam; 🇳🇱 Amsterdam, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

University Medical Center Utrecht, Department of Cardiology; 🇳🇱 Utrecht, Netherlands

Catharina Hospital Eindhoven; 🇳🇱 Eindhoven, Netherlands

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

Skane University Hospital; 🇸🇪 Malmo, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Sweden