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Vascular Implant Safety and Efficacy Study (BIOVITESSE)

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: NCT03263858
Recruitment Status : Active, not recruiting
First Posted : August 28, 2017
Last Update Posted : April 24, 2019
Biotronik AG
Information provided by (Responsible Party):
Biotronik CRC Inc.

Brief Summary:
Assessment of the safety and clinical performance of a coronary stent system in de novo coronary artery lesions

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Intervention Model: Single Group Assignment
Intervention Model Description: consecutive enrolment of cohort 1 (primary endpoint at 1 month), and cohort 2 (primary endpoint at 9 months)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vascular Implant Safety and Efficacy Study
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Cohort 1 and 2 Device: Stent
Implantation of coronary stent in de novo coronary artery lesions

Primary Outcome Measures :
  1. Strut coverage cohort 1 [ Time Frame: 1 month ]
    Strut coverage will be assessed by OCT analysis

  2. In stent late lumen loss cohort 2 [ Time Frame: 9 months ]
    Late lumen loss with will be assessed by central QCA assessment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject is > 18 years and < 85 years old
  2. Written subject informed consent
  3. Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients
  4. Subject is eligible for percutaneous coronary intervention (PCI)
  5. Subject is acceptable candidate for coronary artery bypass surgery
  6. Subject is eligible for Dual Anti Platelet Therapy (DAPT)
  7. Subjects with a maximum of two single discrete de novo lesions in two separate native coronary arteries that can be treated with the study stent during the index procedure
  8. Reference vessel diameter of 3.0 mm to 3.8 mm by visual estimation.
  9. Target lesion length up to 22 mm by visual estimation.
  10. Target lesion with ≥ 50% and < 100% stenosis by visual estimation

Exclusion Criteria:

  1. Left main coronary artery disease
  2. Three-vessel coronary artery disease at the time of index procedure
  3. Angiographic evidence of thrombus in target vessel
  4. Chronic total occlusion
  5. Heavily calcified or extremely tortuous lesions that would prevent complete inflation of a pre-dilatation balloon
  6. Bifurcation lesion requiring side branch intervention, if side branches > 2mm in diameter are involved
  7. Ostial lesions (within 5 mm of vessel origin)
  8. In-stent restenosis
  9. Lesions with prior treatment with a drug coated balloon (DCB)
  10. Target lesion is located in or supplied by an arterial or venous bypass graft
  11. Target lesion requires treatment with. rotational atherectomy
  12. Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
  13. Previous treatment of target vessel within 9 months of index-procedure
  14. Patients with cardiogenic shock
  15. Documented left ventricular ejection fraction (LVEF) ≤ 30%
  16. Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
  17. Hemodynamically unstable NSTEMI or STEMI within 72 hours prior to index procedure
  18. Cerebrovascular event (within 3 months of index procedure)
  19. Subject is receiving oral or intravenous immuno-suppressive therapy (inhaled steroids are allowed) or has known life-limiting immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, but not diabetes mellitus)
  20. Known allergies to: Acetylsalicylic Acid (ASA), heparin, contrast medium, sirolimus, or similar drugs, exipients or the stent material
  21. Triple anticoagulation therapy
  22. Life expectancy less than 1 year
  23. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
  24. Inability to understand or read the informed consent form
  25. Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
  26. In the investigators opinion subjects will not be able to comply with the follow-up requirements

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): NCT03263858

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University Hospital Bern
Bern, Switzerland
Hôpiteaux Universitaires Genève (HUG)
Genève, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland
Cardiocentro Ticino
Lugano, Switzerland
University Hospital Zürich
Zürich, Switzerland
Sponsors and Collaborators
Biotronik CRC Inc.
Biotronik AG

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Responsible Party: Biotronik CRC Inc. Identifier: NCT03263858     History of Changes
Other Study ID Numbers: C1606
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases