Vascular Implant Safety and Efficacy Study

NCT ID: NCT03263858

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2020-01-28

Brief Summary

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

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 and 2

Group Type: EXPERIMENTAL

Stent

Intervention Type: DEVICE

Implantation of coronary stent in de novo coronary artery lesions

Interventions

Stent

Implantation of coronary stent in de novo coronary artery lesions

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: collaborator

Biotronik CRC Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Bern

Bern, , Switzerland

Hôpiteaux Universitaires Genève (HUG)

Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , Switzerland

Cardiocentro Ticino

Lugano, , Switzerland

University Hospital Zürich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

C1606

Identifier Type: -

Identifier Source: org_study_id