Coronary Artery Disease
Conditions
Keywords
Drug eluting stents, Interventional Cardiology
Brief summary
PIONEER-II RCT trial is a prospective, multicenter, randomized, non-inferiority registry trial. 539 subjects from about 40 interventional cardiology centers in China will be enrolled to evaluate In-stent late lumen loss(LLL) as the primary endpoint at 9 months. And all the subjects will be followed up to 5 years to attain the data of the secondary endpoints.
Detailed description
Realizing even more uniform and complete endothelial coverage, BuMA Supreme™ biodegradable drug coating coronary stent system comprises a new generation of biodegradable drug eluting stent under development by SINOMED. BuMA Supreme™ reconfigures BuMA™ DES utilizing a high caliber cobalt chromium platform coated with rapidly degrading PLGA scaffold.
Interventions
DEVICEBuMA Supreme
Stent platform: cobalt-chromium alloy
DEVICEBuMA™
Stent platform: stainless steel
Sponsors
Sino Medical Sciences Technology Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75, male or non-pregnant female 2. Evidence of non-symptomatic ischemia, stable or non-stable angina pectoris or past MI 3. Target lesion is primary and de-novo coronary artery disease 4. The target lesion length ≤ 60 mm, diameter 2.25mm-5.0mm (visually estimated) 5. Lesion diameter stenosis ≥70% (visually estimated) 6. For each target lesion, same stent implantation only 7. Acceptable candidate for coronary artery bypass grafting (CABG) 8. Understand the study purpose, willing to participate and sign the letter of consent, agrees to the follow-up visits including a 9 month angiographic follow-up
Exclusion criteria
1. Acute MI within 1 week 2. Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion 3. More than 3 stents required 4. Patients refuse to be implanted stent 5. Calcified lesion failed in pre-dilation, twisted lesion and lesion unsuitable for stent delivery and expansion 6. In-stent restenosis 7. Planned percutaneous coronary intervention (PCI) within 3 months post procedure 8. Other stents implanted within 1 year 9. Severe heart failure (NYHA above III) or left ventricle ejection fraction (EF) \<40% 10. Renal function damage, blood creatinine \> 176.82 μmol/L 11. Bleeding tendency, active peptic ulcer disease, cerebral or subarachnoid hemorrhage, cerebral apoplexy within half year and contraindication for any anti-platelet or anticoagulation agents 12. Allergic to drugs or agents used in stent or protocol (PLGA, sirolimus, aspirin, clopidogrel, contrast agent, cobalt, nickel, chromium, iron, wolfram et. al.) 13. Life expectation \< 12 months 14. Have not reached the primary end point when participating in other trial 15. Poor compliance to the protocol 16. Heart implantation cases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| in-stent Late Lumen Loss, 9M | QCA at 9-month follow-up window | The primary endpoint is in-stent Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binary restenosis rate | 9 months | Binary restenosis was defined in every segment (proximal, distal, and stent) as a \>50% diameter. |
| in-segment LLL | 9 months | to evaluate the in-sigment Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA). |
| diameter stenosis degree | 9 months | to compare the lumen diameter at 9-month after stent implantation with the baseline diameter as assessed by off-line quantitative coronary angiography (QCA). |
| Stent implantation success rate | 5 years after PCI | The stent implantation success rate includes device success, lesion success and clinical success. |
| Patient-oriented Composite Endpoint (PoCE) | 1, 6, 12 month, and annually up to 5 years post procedure | Patient-oriented Composite Endpoint is defined as all cause death, all myocardial ischemia (MI), or any revascularization. |
| Academic Research Consortium(ARC) defined stent thrombosis | 5 years after PCI | Definite and probable stent thrombosis during acute, subacute, later and very late phase. |
| Device-oriented Composite Endpoint (DoCE) | 1, 6, 12 month, and annually up to 5 years post procedure | Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven target lesion revascularization (TLR). |
Countries
China
Outcome results
None listed