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Vascular Implant Safety and Efficacy Study (BIOVITESSE)

This study is currently recruiting participants.
Verified October 2017 by Biotronik CRC Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03263858
First Posted: August 28, 2017
Last Update Posted: October 31, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Biotronik AG
Information provided by (Responsible Party):
Biotronik CRC Inc.
  Purpose
Assessment of the safety and clinical performance of a coronary stent system in de novo coronary artery lesions

Condition Intervention
Coronary Artery Disease Device: Stent

Study Type: Interventional
Study Design: 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

Further study details as provided by Biotronik CRC Inc.:

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

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


Estimated Enrollment: 66
Actual Study Start Date: August 14, 2017
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 and 2 Device: Stent
Implantation of coronary stent in de novo coronary artery lesions

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03263858


Contacts
Contact: Stephanie Sauter, Dr. +4144864 ext 5575 stephanie.sauter@biotronik.com

Locations
Switzerland
University Hospital Bern Recruiting
Bern, Switzerland
Contact: Lorenz Räber, Prof. Dr.         
Hôpiteaux Universitaires Genève (HUG) Recruiting
Genève, Switzerland
Contact: Marco Roffi, Prof. Dr.         
Centre Hospitalier Universitaire Vaudois (CHUV) Recruiting
Lausanne, Switzerland
Contact: Olivier Muller, Dr.         
Cardiocentro Ticino Recruiting
Lugano, Switzerland
Contact: Marco Moccetti, Dr.         
University Hospital Zürich Recruiting
Zürich, Switzerland
Contact: Patrick Siegrist, Dr.         
Sponsors and Collaborators
Biotronik CRC Inc.
Biotronik AG
  More Information

Responsible Party: Biotronik CRC Inc.
ClinicalTrials.gov Identifier: NCT03263858     History of Changes
Other Study ID Numbers: C1606
First Submitted: August 21, 2017
First Posted: August 28, 2017
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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