Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Firehawk implantation 98 subjects will be enrolled to receive a test device (Firehawk™). |
Device: Firehawk sirolimus target eluting coronary stent system
98 subjects will be enrolled to receive a test device of Firehawk sirolimus target eluting coronary stent system
Other Names:
|
| Active Comparator: XIENCE implantation 98 subjects will be enrolled to receive a control device (XIENCE). |
Device: XIENCE Everolimus-Eluting Coronary Stent System
98 subjects will be enrolled to receive a control device of XIENCE Everolimus-Eluting Coronary Stent System
Other Names:
|
Outcome Measures
Primary Outcome Measures
- In-stent late lumen loss [At 12 months post-index procedure]
Secondary Outcome Measures
- Neo-intimal thickness by Optical Coherence Tomography (OCT) [At 3 months post-index procedure]
Other Outcome Measures
- Target Vessel Failure (TVF) [During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years 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.]
- 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.]
- Mean/Minimal Stent area (mm2) [At 3 months and 12 months 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.]
Eligibility Criteria
Criteria
Clinical Inclusion Criteria:
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CI1. Subject must be at least 18 years of age;
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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;
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CI3. Subject is eligible for percutaneous coronary intervention (PCI);
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CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
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CI5. Subjects are eligible candidates for coronary artery bypass graft surgery (CABG);
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CI6. Left ventricular ejection fraction (LVEF) within 60 days ≥ 35%; Exclusion Criteria;
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CI7. Subject is willing to comply with all protocol-required follow-up evaluation.
Angiographic Inclusion Criteria (visual estimate):
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AI1. Target lesions must be new and have a visually estimated reference diameter ≥2.25 mm and ≤4.0 mm in autologous coronary artery;
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AI2. Target lesions must be < 100 mm in length (visual estimate) and the number of implanted stents is less than 4;
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AI3. Target lesions must be visually complete occlusion and longer than 4 weeks;
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AI4. Target lesions must be able to pass and be successfully expanded;
Clinical Exclusion Criteria:
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CE1. Subjects recently suffer from MI (within 1 week), and ECG changes/clinical symptoms consistent with AMI or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) are excluded;
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CE2. Subjects had an organ transplant or are waiting for an organ transplant;
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CE3. Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days after PCI;
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CE4. Subjects are undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome;
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CE5. Subjects with abnormal counts of platelet and white blood cell (WBC): platelet counts less than 100×10E9/L or greater than 700×10E9/L, white blood cells less than 3×10E9/L;
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CE6. Subjects have confirmed or suspected liver disease, including hepatitis lab results;
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CE7. Subjects with elevated serum creatinine level >3.0mg/dL or undergoing dialysis therapy;
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CE8. Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion;
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CE9. Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months, or with permanent nerve defects;
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CE10. Subjects had any PCI (such as balloon angioplasty, stent, cutting balloon,atherectomy) treatment in target vessels (including collateral) within 12 months prior to baseline;
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CE11. Subjects plan to undergo PCI or CABG after the baseline PCI;
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CE12. Subjects have any coronary endovascular brachytherapy treatment previously;
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CE13. Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thiophenepyridine or aspirin);
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CE14. Subjects are suffering from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 18 months;
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CE15. Subjects are currently abusing drugs (such as alcohol, cocaine, heroin, etc);
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CE16. Subject plan to undergo any operations that may lead to confuse with the programme;
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CE17. Subjects were participating in another study of drug or medical device which did not meet its primary endpoint;
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CE18. Subjects plan to pregnant within 18 months after baseline;
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CE19. Subjects are pregnant or breastfeeding women.
Angiographic Exclusion Criteria (visual estimate):
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AE1. Target lesions with the following criteria: left main, saphenous vein grafts or arterial grafts, via saphenous vein grafts or arterial graft, and in-stent stenosis;
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AE2. Subjects with unprotected left main coronary artery disease (diameter stenosis
50%);
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AE3. Subjects have a protected left main coronary artery disease (diameter stenosis> 50% and left coronary artery bypass surgery), as well as target lesions located in the LAD and LCX;
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AE4. Subjects with other lesions of clinical significance, may be need intervention within 18 months after baseline.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The General Hospital of Shenyang Military | Shenyang | Liaoning | China |
Sponsors and Collaborators
- Shanghai MicroPort Medical (Group) Co., Ltd.
Investigators
- Principal Investigator: Yaling Han, MD, The General Hospital of Shenyang Military
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TARGET CTO