NCT04150016UnknownNot Applicable
Assessment of In-stent Intimal Repair and Vessel Reaction After FirehawkTM Sirolimus Eluting Stent Implantation of STEMI Subjects - An Optical Coherence Tomography (OCT) Study
Xijing Hospital1 site in 1 country44 target enrollmentStarted: March 8, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Neointimal thickness by OCT
Study Overview
Brief Summary
This study is a prospective, multi-center, non-inferior, randomized controlled clinical trial, aims to use optical Coherence tomography to observe the the early- and mid-stage vessel repair and neointimal proliferation. And 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 ST-elevation myocardial infarction (STEMI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical Inclusion Criteria:
- •Subject must be 18 - 75 years of age; male or female without pregnancy.
- •Subjects recently suffer from SETMI (from 20 minute to 12 hours), and ECG changes consistent with AMI:
- •1mm elevation in more than 2 continuously leads, or; Newly developed LBBB, or;
- •1mm depression in more than 2 continuously leads representing Posterior myocardial infarction) CI
- •New, in situ and single or bifurcation lesion of target vessel. CI
- •Subject only implanted one brand of stent. CI
- •Subjects are eligible candidates for coronary artery bypass graft surgery (CABG).
- •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;
- •Angiographic Inclusion Criteria:
- •At least one of the target lesions must be acute occlusion lesion, and Eligible for percutaneous coronary intervention (PCI), and Having a visually estimated diameter restenosis no less than 70% (or a visually estimated diameter restenosis no less than 50% with consistent clinical symptoms), TIMI blood flow no less than Grade I, and have a visually estimated reference diameter ≥2.25 mm and ≤4.0 mm.
- •Target lesions must be able to pass through all target lesions (no severe tortuosity or calcification in proximal lesion).
- •Target lesions of type A lesion defined by ACC/AHA must be successfully expanded (no severe calcification in target lesion).
Exclusion Criteria
- •Subjects with Cardiogenic shock. CE
- •Subjects with severe heart failure (NYHA classification ≥ 3) or LVEF<35%. CE
- •Subjects with elevated serum creatinine level >2.0mg/dL or undergoing dialysis therapy.
- •Subjects associated with drugs allergy (such as sirolimus, everolimus, stent alloys, contrast medium, heparin, clopidogrel or aspirin).
- •Subjects with bleeding tendency, active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion.
- •Subjects with cardiac stroke or with sequelae of stroke. CE
- •Subjects with cebral tumor, Cerebral aneurysms, cerebral arteriovenous malformation (AVM), transient ischemic attack (TIA), permanent nerve defects, GI bleeding within 2 months, major operation within 6 weeks, or with abnormal counts of platelet and hemoglobin (Hb): platelet counts less than 1×106/mm3, Hb less than 10g/dL.
- •Subjects plan to undergo any operations within 6 months that may lead to anti-platelet therapy discontinuation.
- •Subjects are suffering from other serious illness, which may cause drop in life expectancy to less than 12 months.
- •Subjects were participating in another study of drug or medical device, which did not meet its primary endpoint.
- •Subject are considered unwilling to understand the trial requirements and refused to follow the treatment procedures.
- •Subject with Heart transplantation.
- •Angiographic Exclusion Criteria:
- •Target lesions with true bifurcation lesion (both main and branch vessel need implantation).
- •Target lesions with unprotected left main. AE
- •Target lesions with more than 100mm in length. AE
- •Target lesions with in-stent stenosis. AE
- •Uncertain target lesions. AE
- •Target lesion unsuitable for 6 months OCT follow up.
Outcomes
Primary Outcomes
Neointimal thickness by OCT
Time Frame: At 6 months post-index procedure
Secondary Outcomes
- Thrombosis (from ARC definition)(30 days, 6 months, 12 months post-index procedure)
- Percentage of Uncovered Struts by OCT(At 6 months post-index procedure)
- Target lesion failure(30 days, 6 months, 12 months post-index procedure)
- In-stent and in-segment late lumen loss(At 6 months post-index procedure)
- Percentage of Malaposition Struts by OCT(At 6 months post-index procedure)
Investigators
Study Sites (1)
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