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

Phase 3

Completed

Conditions: coronary artery disease
narrowing of the coronary artery
10011082

Registration Number: NL-OMON55926

Lead Sponsor: Elixir Medical Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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.
• If patient is presenting with STEMI, enrollment should take place only if
sufficient research staff is available and the center is trained to perform PCI
in an acute setting
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.
• If a non-target lesion is present, it must have been treated successfully and
without complication** prior to proceeding with treatment of the target lesion
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
*The definition of epicardial vessels is the LAD, LCx and RCA, and is inclusive
of their branches. For example, the patient must not have lesions requiring
treatment in both the LAD and a diagonal branch.
**Assessment of successful treatment of the non-target lesion will be per
physician*s decision, however, acute complications and/or adverse events
associated with the non-target lesion should be considered unsuccessful.
Examples of unsuccessful treatment include but are not limited to: inability to
deploy stent, major dissection requiring multiple stent placement, stent
embolization, ST, prolonged chest pain, persistent ECG changes, etc.
Additional Inclusion Criteria for PK study:
11. Patients participating in PK study 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 scoring 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 P

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint<br /><br>The primary endpoint is target lesion failure (TLF) at 3 days or through<br /><br>hospital discharge, whichever comes first. Target lesion failure (TLF) is<br /><br>defined as a per-subject hierarchical count of cardiovascular death, target<br /><br>vessel MI, and clinically-indicated target lesion revascularization.</p><br>

Secondary Outcome Measures

Name	Time	Method

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