Coronary Artery Disease
Conditions
Keywords
Drug Eluting Coronary Stent
Brief summary
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.
Detailed 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.
Interventions
COMBINATION_PRODUCTPercutaneous Coronary Intervention with drug eluting stents
Coronary drug eluting stent implantation
Sponsors
Elixir Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
single blind
Intervention model description
prospective, multi-center, single blind, randomized clinical study. Randomization is 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 3 days or through hospital discharge, whichever comes first | defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 30 days | defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target lesion revascularization |
| Death | 3 days or through hospital discharge, whichever comes first | Cardiovascular and Non-cardiovascular |
| Myocardial Infarction | 3 days or through hospital discharge, whichever comes first | Q-wave and non-Q-wave; Target vessel and non-target vessel |
| Target Lesion Revascularization | 3 days or through hospital discharge, whichever comes first | Clinically indicated and non-clinically indicated |
| Acute success | during hospital stay with a maximum of first seven days post index procedure | defined as the successful delivery of the designated device and a final residual stenosis \< 30% by QCA without TLF |
| Late Lumen Loss | 6 months | powered secondary endpoint assessed by QCA in a subset of patients |
| Optical Coherence Tomography (OCT) imaging | Post procedure and 6 months | assessment of the lesion and stent in a subset of patients. |
| Pharmacokinetic profile of the drugs on the DESyne BDS Plus Stent | pre-treatment, and post-treatment at 10 minutes, 30 minutes, 1, 2, 4, 6, 12, 24, 72 hours, and 7 days | assessment of the blood pharmacokinetics of the three drugs eluted from the DESyne BDS Plus after implantation |
| Target Vessel Failure | 3 days or through hospital discharge, whichever comes first | per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically-indicated target vessel revascularization |
Countries
Belgium, Brazil, Czechia, Netherlands, New Zealand
Outcome results
None listed