The DESyne BDS Plus RCT: A Randomized Clinical Trial to Assess the Elixir DESyne BDS Plus Drug Eluting Coronary Stent System for the Treatment of de Novo Native Coronary Artery Lesions

The DESyne BDS Plus RCT: A Randomized Clinical Trial to Assess the Elixir DESyne BDS Plus Drug Eluting Coronary Stent System for the Treatment of de Novo Native Coronary Artery Lesions

The objective of this clinical trial is to confirm the safety, effectiveness and performance of the DESyne BDS Plus Drug Eluting Coronary Stent System (DESyne BDS Plus DECSS) (Test) as compared to the CE Mark approved DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) (Control) in the treatment of de novo native coronary artery lesions.

The DESyne BDS Plus Randomized Clinical Trial is a prospective, multi-center, single blind, randomized clinical study. Randomization (1:1; DESyne BDS Plus : DESyne X2) of up to 200 patients (100 in each arm) requiring treatment of up to two de novo coronary artery lesions ≤ 34 mm in length in vessels ≥ 2.25 mm and ≤ 3.5 mm in diameter will be conducted. The study will be conducted in two parts, with randomization of the first 100 subjects (Cohort 1) followed by the randomization of an additional 100 subjects (Cohort 2).

In an imaging subset of approximately 60 subjects (30 per arm), Angiography and OCT will be performed at index procedure, and again at 6-month follow-up.

The PK sub-study will enroll up to 10 non-randomized subjects treated only with the DESyne BDS Plus device, with a maximum of three DESyne BDS Plus stents implanted. The PK sub-study is being conducted to assess the blood pharmacokinetics of the three drugs (Sirolimus, Rivaroxaban, Argatroban) eluted from the DESyne BDS Plus after implantation. PK measurements will be conducted at 10 minutes, 30 minutes, 1, 2, 4, 6, 12, 24, 72 hours, and 7 days. In addition, all PK subjects will undergo clinical assessments/follow-up at 3 days or hospital discharge (whichever comes first), 1 month, 6 months, 12 months, 2 years, and 3 years.

Inclusion Criteria:

1. Patient must be at least 18 years of age

2. Patient is able to understand the risks, benefits and treatment alternatives of receiving the DESyne BDS Plus DECSS or the DESyne X2 NECSS and provide written informed consent or oral consent (in urgent PCI) as allowed per hospital standard and as approved by the local Ethics Committee, prior to any clinical study-related procedure

3. Indication for a percutaneous intervention with stent implantation in native epicardial arteries including patients with stable coronary artery disease and acute coronary syndromes including NSTEMI and STEMI.

4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery

5. Patient agrees to undergo all clinical study required follow up visits, angiograms, and imaging testing (as applicable)

6. Patient agrees not to participate in any other clinical research study for a period of one year following the index procedure (long term follow-up or observational studies are permitted)

   Angiographic Inclusion Criteria

7. Target lesion(s) must be de novo coronary artery lesion(s) and must be located in a separate* vessel from other target or non-target lesions.

8. Target lesion(s) must have a reference vessel diameter (RVD) of ≥ 2.25 and ≤ 3.5 mm by visual estimation

9. Target lesion(s) must measure ≤ 34 mm in length, and able to be covered by a single device with 2 mm of healthy vessel on either side of planned implantation site

10. Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and <100%. When two target lesions are treated, they must be located in separate major epicardial vessels

    Additional Inclusion Criteria for PK study:

11. Patients participating in PK study must meet all general and angiographic inclusion/exclusion criteria and may be treated with only the DESyne BDS Plus during Index Procedure.

Exclusion Criteria:

1. Acute myocardial infarction with Killip Class III and IV

2. Acute myocardial infarction requiring resuscitation

3. Acute myocardial infarction requiring IABP or ventilation support

4. Patient had fibrinolysis prior to PCI

5. Patient has current unstable ventricular arrhythmias

6. Patient has a known left ventricular ejection fraction (LVEF) < 30%

7. Patient has received a heart transplant or any other organ transplant or is on a waiting list for an organ transplant

8. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure

9. Patient is receiving immunosuppression therapy, other than steroids or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)

10. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, Novolimus, Sirolimus, Rivaroxaban, Argatroban, CoCr alloys, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated

11. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors

12. Patient has severe renal dysfunction (CKD IV or V, eGFR <30) or is on dialysis

13. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months

14. Patient has had a significant GI or urinary bleed within the past six months

15. Women of childbearing potential (unless they have a negative pregnancy test within 7 days of index procedure), or women who are pregnant or nursing

16. Patient has other medical conditions or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation, or be associated with a limited life expectancy (i.e., less than one year)

17. Patient is already participating in another clinical study which has not reached the primary endpoint (long-term follow-up or observational studies are permitted)

    Angiographic Exclusion Criteria

18. Patient with vessel rupture and/or visible pericardial effusion

19. Target lesion aorto-ostial location or within 5mm of the origin of the vessel (LAD, LCX, RCA)

20. Target lesion is severely calcified and/or requires use of rotational atherectomy or cutting balloon, the use of shockwave or scoring balloon is allowed

21. Target Lesion located in the Left Main artery

22. Target Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft

23. Target Lesion involves a bifurcation >2.5 mm, or which requires a planned 2 or more stent technique

24. Previous placement of a stent within 10 mm of a target lesion

25. Another clinically-significant lesion (> 50%) is located in the same major epicardial vessel as a target lesion

26. Target vessel was previously treated with any type of PCI < 6 months prior to index procedure

27. Unsuccessful or complicated PCI in a non-target vessel < 48 hours prior to index procedure

28. Target vessel has a planned staged PCI ≤ 6 months after the index procedure

    Additional Exclusion Criteria for PK study:

29. Target vessel was previously treated with any type of PCI < 6 months prior to index procedure

30. Patient with planned staged PCI within 90 days after study procedure

31. Patients who have a non-target lesion treated during the study procedure