Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System (DIRECT II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Svelte Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01788150
First received: February 5, 2013
Last updated: March 24, 2014
Last verified: March 2014

February 5, 2013
March 24, 2014
January 2013
May 2014   (final data collection date for primary outcome measure)
  • Angiographic Target Vessel Failure (TVF) [ Time Frame: 6-months post-procedure ] [ Designated as safety issue: Yes ]
  • Angiographic in-Stent Late Lumen Loss (LL) [ Time Frame: 6-months post-procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01788150 on ClinicalTrials.gov Archive Site
  • Clinically-driven Target Lesion Revascularization (TLR) [ Time Frame: 1 and 6-months and yearly through 5-years post-procedure ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization [ Time Frame: 1 and 6-months post-procedure, and yearly up to 5-years ] [ Designated as safety issue: Yes ]
  • Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of non target vessels [ Time Frame: 5-years post-procedure ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 1 and 6-months and yearly for 5-years post-procedure ] [ Designated as safety issue: Yes ]
  • Acute success rates [ Time Frame: From index procedure to hospital discharge ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment angiographic binary restenosis rate [ Time Frame: 6-months post-procedure ] [ Designated as safety issue: No ]
  • In-stent and in-segment minimum lumen diameter [ Time Frame: 6-months post-procedure ] [ Designated as safety issue: No ]
  • In-segment late lumen loss [ Time Frame: 6-months post-procedure ] [ Designated as safety issue: No ]
  • Neointimal hyperplasia (% lumen volume) [ Time Frame: 6 months post procedures ] [ Designated as safety issue: No ]
  • Strut coverage (% of struts malapposed, protruding non-covered, protruding covered, non-protruding covered) [ Time Frame: 6 months post procedure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System
Direct Implantation of Rapamycin-Eluting Stents With Bio-Erodible Drug Carrier Technology Utilizing the Second Generation Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS)

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Device: Coronary Stenting
  • Experimental: Svelte Drug-Eluting Coronary Stent
    Coronary Stenting
    Intervention: Device: Coronary Stenting
  • Active Comparator: Medtronic Resolute Integrity Drug-Eluting Stent
    Coronary Stenting
    Intervention: Device: Coronary Stenting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
159
May 2019
May 2014   (final data collection date for primary outcome measure)

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%).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   France,   Belgium,   Switzerland,   Germany,   Sweden,   Czech Republic
 
NCT01788150
IP-12-002
Yes
Svelte Medical Systems, Inc.
Svelte Medical Systems, Inc.
Not Provided
Principal Investigator: Stefan Verheye, MD, PhD Antwerp Cardiovascular Institute
Principal Investigator: Alexandre Abizaid, MD, PhD Instituto Dante Pazzanese de Cardiologia
Svelte Medical Systems, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP