Vascular Implant Safety and Efficacy Study (BIOVITESSE)

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Stent

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland
    • University Hospital Bern
  • Genève, Switzerland
    • Hôpiteaux Universitaires Genève (HUG)
  • Lausanne, Switzerland
    • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Lugano, Switzerland
    • Cardiocentro Ticino
  • Zürich, Switzerland
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strut coverage cohort 1	Strut coverage will be assessed by OCT analysis	1 month
In stent late lumen loss cohort 2	Late lumen loss with will be assessed by central QCA assessment	9 months

Collaborators and Investigators

• Sponsor: Biotronik CRC Inc.
• Collaborators: Biotronik AG

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): November 4, 2019
• Study Completion (Actual): January 28, 2020

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: C1606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No