Status and phase
Conditions
Treatments
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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 must meet all general and angiographic inclusion/exclusion criteria and 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 shockwave or scoring balloon 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
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal