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
  Purpose

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


Condition Intervention
Coronary Artery Disease
Device: Coronary Stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Svelte Medical Systems, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 159
Study Start Date: January 2013
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Svelte Drug-Eluting Coronary Stent
Coronary Stenting
Device: Coronary Stenting
Active Comparator: Medtronic Resolute Integrity Drug-Eluting Stent
Coronary Stenting
Device: Coronary Stenting

  Eligibility

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

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%).
  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 ClinicalTrials.gov identifier: NCT01788150

Locations
Belgium
OLV Ziekenhuis Aalst
Aalst, Belgium
Middelheim Ziekenhuis
Antwerpen, Belgium
ZOL Genk
Genk, Belgium
CHU Liège
Liege, Belgium
Czech Republic
Všeobecná fakultní nemocnice Praha
Prague, Czech Republic
France
Clinique Saint-Hilaire
Rouen, France
Clinique Pasteur
Toulouse, France
CHU de Toulouse
Toulouse, France
Germany
Medizinisches Verzorgungszentrum Prof. Mathey, Prof. Schofer
Hamburg, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Netherlands
OLVG Amsterdam
Amsterdam, Netherlands
Catharina Hospital Eindhoven
Eindhoven, Netherlands
Erasmus MC
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
University Medical Center Utrecht, Department of Cardiology
Utrecht, Netherlands
Sweden
Skane University Hospital
Malmo, Sweden
Södersjukhuset
Stockholm, Sweden
Switzerland
Inselspital
Bern, Switzerland
Sponsors and Collaborators
Svelte Medical Systems, Inc.
Investigators
Principal Investigator: Stefan Verheye, MD, PhD Antwerp Cardiovascular Institute
Principal Investigator: Alexandre Abizaid, MD, PhD Instituto Dante Pazzanese de Cardiologia
  More Information

Additional Information:
No publications provided

Responsible Party: Svelte Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01788150     History of Changes
Other Study ID Numbers: IP-12-002
Study First Received: February 5, 2013
Last Updated: March 24, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014