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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01788150
Recruitment Status : Active, not recruiting
First Posted : February 11, 2013
Last Update Posted : April 2, 2018
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Coronary Stenting Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : January 2013
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: Svelte Drug-Eluting Coronary Stent
Coronary Stenting
Device: Coronary Stenting
Active Comparator: Medtronic Resolute Integrity Drug-Eluting Stent
Coronary Stenting
Device: Coronary Stenting

Primary Outcome Measures :
  1. Angiographic Target Vessel Failure (TVF) [ Time Frame: 6-months post-procedure ]
    The composite endpoint comprised of cardiac death, target vessel MI (Q or Non Q-Wave), or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.

  2. Angiographic in-Stent Late Lumen Loss (LL) [ Time Frame: 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 :
  1. Clinically-driven Target Lesion Revascularization (TLR) [ Time Frame: 1 and 6-months and yearly through 5-years 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.

  2. 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 ]
    Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization

  3. 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 ]
    Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of non target vessels

  4. Stent thrombosis [ Time Frame: 1 and 6-months and yearly for 5-years post-procedure ]
    The sudden occlusion of a stented coronary artery due to thrombus formation.

  5. Acute success rates [ Time Frame: From index procedure to hospital discharge ]
    Device Success, Direct Stenting Success, Lesion Success and procedure Success

  6. In-stent and in-segment angiographic binary restenosis rate [ Time Frame: 6-months post-procedure ]
    The rate which restenosis occurs

  7. In-stent and in-segment minimum lumen diameter [ Time Frame: 6-months post-procedure ]
    smallest diameter in the stent or segment area

  8. In-segment late lumen loss [ Time Frame: 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

  9. Neointimal hyperplasia [ Time Frame: 6 months post procedures ]
    (% lumen volume)

  10. Strut coverage [ Time Frame: 6 months post procedure ]
    (% of struts malapposed, protruding non-covered, protruding covered, non-protruding covered)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01788150

OLV Ziekenhuis Aalst
Aalst, Belgium
Middelheim Ziekenhuis
Antwerpen, Belgium
ZOL Genk
Genk, Belgium
CHU Liège
Liege, Belgium
Všeobecná fakultní nemocnice Praha
Prague, Czechia
Clinique Saint-Hilaire
Rouen, France
CHU de Toulouse
Toulouse, France
Clinique Pasteur
Toulouse, France
Medizinisches Verzorgungszentrum Prof. Mathey, Prof. Schofer
Hamburg, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
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
Skane University Hospital
Malmo, Sweden
Stockholm, Sweden
Bern, Switzerland
Sponsors and Collaborators
Svelte Medical Systems, Inc.
Principal Investigator: Stefan Verheye, MD, PhD Antwerp Cardiovascular Institute
Principal Investigator: Alexandre Abizaid, MD, PhD Instituto Dante Pazzanese de Cardiologia

Additional Information:
Responsible Party: Svelte Medical Systems, Inc. Identifier: NCT01788150     History of Changes
Other Study ID Numbers: IP-12-002
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

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