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
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug Eluting Coronary Stent
Eligibility Criteria
Inclusion Criteria:
- Patient must be at least 18 years of age
- 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
- 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.
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
- Patient agrees to undergo all clinical study required follow up visits, angiograms, and imaging testing (as applicable)
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
- 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.
- Target lesion(s) must have a reference vessel diameter (RVD) of ≥ 2.25 and ≤ 3.5 mm by visual estimation
- 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
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:
- Patients participating in PK study may be treated with only the DESyne BDS Plus during Index Procedure.
Exclusion Criteria:
- Acute myocardial infarction with Killip Class III and IV
- Acute myocardial infarction requiring resuscitation
- Acute myocardial infarction requiring IABP or ventilation support
- Patient had fibrinolysis prior to PCI
- Patient has current unstable ventricular arrhythmias
- Patient has a known left ventricular ejection fraction (LVEF) < 30%
- Patient has received a heart transplant or any other organ transplant or is on a waiting list for an organ transplant
- Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
- Patient is receiving immunosuppression therapy, other than steroids or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
- 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
- Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors
- Patient has severe renal dysfunction (CKD IV or V, eGFR <30) or is on dialysis
- Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
- Patient has had a significant GI or urinary bleed within the past six months
- Women of childbearing potential (unless they have a negative pregnancy test within 7 days of index procedure), or women who are pregnant or nursing
- 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)
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
- Patient with vessel rupture and/or visible pericardial effusion
- Target lesion aorto-ostial location or within 5mm of the origin of the vessel (LAD, LCX, RCA)
- Target lesion is severely calcified and/or requires use of rotational atherectomy or cutting balloon, the use of scoring is allowed
- Target Lesion located in the Left Main artery
- Target Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
- Target Lesion involves a bifurcation >2.5 mm, or which requires a planned 2 or more stent technique
- Previous placement of a stent within 10 mm of a target lesion
- Another clinically-significant lesion (> 50%) is located in the same major epicardial vessel as a target lesion
- Target vessel was previously treated with any type of PCI < 6 months prior to index procedure
- Unsuccessful or complicated PCI in a non-target vessel < 48 hours prior to index procedure
Target vessel has a planned staged PCI ≤ 6 months after the index procedure
Additional Exclusion Criteria for PK study:
- Target vessel was previously treated with any type of PCI < 6 months prior to index procedure
- Patient with planned staged PCI within 90 days after study procedure
- Patients who have a non-target lesion treated during the study procedure
Sites / Locations
- ZNA Middelheim
- AZ Sint Jan Brugge Oostende AV
- Ziekenhuis Oost-Limburg, Campus Sint Jan
- Universitaire Ziekenhuizen Leuven
- Instituto Dante Pazzanese
- Instituto do Coração da Faculdade
- General University Hospital
- Catharina Hospital
- North Shore Hospital
- Auckland City Hospital
- Middlemore Hospital
- Christchurch Hospital
- Dunedin Hospital
- Waikato Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
DESyne BDS Plus Arm
DESyne X2 Arm
DESyne BDS Plus Drug Eluting Coronary Stent System (DESyne BDS Plus DECSS; DESyne BDS Plus) is loaded with Sirolimus, Rivaroxaban and Argatroban
The DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) is loaded with Novolimus