To Study the safety and efficacy of drug releasing Orsiro Cardiac stent in patients with Coronary Artery Diseases

Phase 2

• Conditions: Health Condition 1: null- Coronary Artery Disease

• Registration Number: CTRI/2011/07/001928
• Lead Sponsor: BIOTRONIK AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Patient has provided a written informed consent

2. Patient is ≥ 18 and ≤80 years old

3. Single de novo lesion with ≥50% and 100% stenosis in up to 2 coronary arteries

4. Patient, target vessel(s) and lesion(s) are eligible for PCI with the Orsiro stent

5. The target lesion length is ≤26 mm (assessed either visually or by online QCA) and can be covered by one clinical investigation stent

6. The target reference vessel diameter is ≥2.0 mm and ≤ 4.0 mm (assessed either visually or by online QCA)

7. Target vessel(s) with TIMI flow ≥2

8. Patient is an acceptable candidate for CABG

9. Clinical evidence of stable or unstable angina pectoris or documented silent ischemia

10. Eligible for DAPT treatment with ASA plus either, Clopidogrel, Prasugrel, Ticlopidineor Ticagrelor

Exclusion Criteria

Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the clinical investigation

2. Evidence of myocardial infarction within 72 hours prior to the index procedure

3. Patients with CKMB and/or Troponin levels exceeding the normal range within 24 hours prior to the procedure

4. Unprotected Left Main coronary artery disease (stenosis 50%)

5. Three-vessel coronary artery disease at time of procedure

6. Thrombus in target vessel

7. Planned interventional treatment of any non-target vessel within 30 days post-procedure.

8. Planned intervention of the target vessels after the index

9. Ostial target lesion (within 5.0mm of vessel origin)

10. Target lesion involves a side branch 2.0mm in diameter

11. Documented left ventricular ejection fraction (LVEF) ≤30%

12. Heavily calcified lesion which cannot be successfully pre-dilated;

13. Target lesion is located in or supplied by an arterial or venous bypass graft

14. The target lesion requires treatment with a device other than the pre-dilatation balloon prior to stent placement (including but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, cutting balloon etc.)

15. Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus or drugs similar to Sirolimus (i.e. Everolimus, ABT 578, Biolimus,Tacrolimus); CoCr, PLLA, Silicon Carbide

16. Impaired renal function (serum creatinine 2.5mg/dl or 221mol/l, determined within 72 hours prior to intervention)

17. Patient is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)

18. Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off

19. Life expectancy less than 1 year.

20. Planned surgery or dental surgical procedure within12 months after index

procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified