Vascular Implant Safety and Efficacy Study

Coronary Artery Disease Clinical Trial

— BIOVITESSE  

Official title:

Vascular Implant Safety and Efficacy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263858
• Other study ID #: C1606
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: January 28, 2020

Study information

• Verified date: July 2020
• Source: Biotronik CRC Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 28, 2020
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Stent
Implantation of coronary stent in de novo coronary artery lesions

Locations

Country	Name	City	State
Switzerland	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

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik CRC Inc.	Biotronik AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strut coverage cohort 1	Strut coverage will be assessed by OCT analysis	1 month
Primary	In stent late lumen loss cohort 2	Late lumen loss with will be assessed by central QCA assessment	9 months