Drug-Eluting Stents, Percutaneous Coronary Intervention, Tomography, Optical Coherence
Conditions
Brief summary
This study is a prospective, multi-center, open-label, randomized controlled clinical trial,aims to assess the safety and effectiveness of the Firehawk™ sirolimus target-eluting coronary stent system with abluminal grooves containing a biodegradable polymer (Firehawk™) comparing the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with total coronary occlusion lesion(s).
Detailed description
This study will recruit 196 subjects with total coronary occlusion lesion(s) in coronary arteries ≥2.25 mm to ≤4.0 mm in diameter and ≤100 mm in length (by visual estimate) in no more than 10 research centers in China. All participants met the inclusion criteria will be 1:1 randomized to receive Firehawk™ sirolimus target-eluting coronary stent or XIENCE everolimus-eluting coronary stent. Optical Coherent Tomography (OCT) sub study: the first 44 consecutive subjects who consented to participate in the OCT sub study will undergo OCT assessment at 3 months and 12 months post index procedure. The OCT sub study will be performed in 3-5 pre-selected sites. The clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months,and 2-5 years post-index procedure.The primary endpoint is in-stent late lumen loss at 12 months post-index procedure.The secondary endpoint is neo-intimal thickness by Optical Coherent Tomography (OCT) at 3 months post-index procedure.
Interventions
DEVICEFirehawk sirolimus target eluting coronary stent system
98 subjects will be enrolled to receive a test device of Firehawk sirolimus target eluting coronary stent system
DEVICEXIENCE Everolimus-Eluting Coronary Stent System
98 subjects will be enrolled to receive a control device of XIENCE Everolimus-Eluting Coronary Stent System
Sponsors
Shanghai MicroPort Medical (Group) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: * CI1. Subject must be at least 18 years of age; * CI2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; * CI3. Subject is eligible for percutaneous coronary intervention (PCI); * CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia; * CI5. Subjects are eligible candidates for coronary artery bypass graft surgery (CABG); * CI6. Left ventricular ejection fraction (LVEF) within 60 days ≥ 35%;
Exclusion criteria
; * CI7. Subject is willing to comply with all protocol-required follow-up evaluation. Angiographic Inclusion Criteria (visual estimate): * AI1. Target lesions must be new and have a visually estimated reference diameter ≥2.25 mm and ≤4.0 mm in autologous coronary artery; * AI2. Target lesions must be \< 100 mm in length (visual estimate) and the number of implanted stents is less than 4; * AI3. Target lesions must be visually complete occlusion and longer than 4 weeks; * AI4. Target lesions must be able to pass and be successfully expanded; Clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent late lumen loss | At 12 months post-index procedure |
Secondary
| Measure | Time frame |
|---|---|
| Neo-intimal thickness by Optical Coherence Tomography (OCT) | At 3 months post-index procedure |
Other
| Measure | Time frame |
|---|---|
| Target Vessel Revascularization (TVR) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. |
| Target Lesion Revascularization (TLR) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. |
| Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. |
| Death (All cause, Cardiac, Non-cardiac) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. |
| Cardiac Death/ All Myocardial Infarction | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. |
| Stent Thrombosis (per ARC definition) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. |
| In-stent and in-segment percent diameter stenosis (DS%) | At 12 months post-index procedure. |
| In-segment late lumen loss | At 12 months post-index procedure. |
| In-stent and in-segment minimum lumen diameter (MLD) | At 12 months post-index procedure. |
| In-stent and in-segment binary restenosis rate (%) | At 12 months post-index procedure. |
| Target Vessel Failure (TVF) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. |
| Mean/Minimal Lumen area (mm2) | At 3 months and 12 months post-index procedure. |
| Lumen volume (mm3) | At 3 months and 12 months post-index procedure. |
| Stent volume (mm3) | At 3 months and 12 months post-index procedure. |
| Mean neointimal hyperplasia area (mm2) | At 3 months and 12 months post-index procedure. |
| In-stent neointimal hyperplasia volume obstruction (%) | At 3 months and 12 months post-index procedure. |
| Uncovered strut rate (%) | At 3 months and 12 months post-index procedure. |
| Malapposed strut rate (%) | At 3 months and 12 months post-index procedure. |
| Malposed and uncovered strut rate (%) | At 3 months and 12 months post-index procedure. |
| Technical success rate | Instantly after index procedure. |
| Clinical procedural success rate | At time of procedure up to 7 days in hospital. |
| Mean/Minimal Stent area (mm2) | At 3 months and 12 months post-index procedure. |
| Target Lesion Failure (TLF) | During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. |
Countries
China
Outcome results
None listed