Clinical trial NCT04150016: In-stent Repair and Vessel Reaction of STEMI Patients With OCT
Official title: Assessment of In-stent Intimal Repair and Vessel Reaction After FirehawkTM Sirolimus Eluting Stent Implantation of STEMI Subjects - An Optical Coherence Tomography (OCT) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug-eluting Stents
Percutaneous Coronary Intervention
Optical Coherence Tomography
ST-Elevation Myocardial Infarction
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Clinical Inclusion Criteria:

CI1. Subject must be 18 - 75 years of age; male or female without pregnancy.

CI2. 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) CI3. New, in situ and single or bifurcation lesion of target vessel. CI4. Subject only implanted one brand of stent. CI5. Subjects are eligible candidates for coronary artery bypass graft surgery (CABG).

CI6. 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:

AI1. 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.

AI2. Target lesions must be able to pass through all target lesions (no severe tortuosity or calcification in proximal lesion).

AI3. Target lesions of type A lesion defined by ACC/AHA must be successfully expanded (no severe calcification in target lesion).

Clinical Exclusion Criteria:

CE1. Subjects with Cardiogenic shock. CE2. Subjects with severe heart failure (NYHA classification ≥ 3) or LVEF\<35%. CE3. Subjects with elevated serum creatinine level \>2.0mg/dL or undergoing dialysis therapy.

CE4. Subjects associated with drugs allergy (such as sirolimus, everolimus, stent alloys, contrast medium, heparin, clopidogrel or aspirin).

CE5. Subjects with bleeding tendency, active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion.

CE6. Subjects with cardiac stroke or with sequelae of stroke. CE7. 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.

CE8. Subjects plan to undergo any operations within 6 months that may lead to anti-platelet therapy discontinuation.

CE9. Subjects are suffering from other serious illness, which may cause drop in life expectancy to less than 12 months.

CE10. Subjects were participating in another study of drug or medical device, which did not meet its primary endpoint.

CE11. Subject are considered unwilling to understand the trial requirements and refused to follow the treatment procedures.

CE12. Subject with Heart transplantation.

Angiographic Exclusion Criteria:

AE1. Target lesions with true bifurcation lesion (both main and branch vessel need implantation).

AE2. Target lesions with unprotected left main. AE3. Target lesions with more than 100mm in length. AE4. Target lesions with in-stent stenosis. AE5. Uncertain target lesions. AE6. Target lesion unsuitable for 6 months OCT follow up.

Primary outcomes:
measure: Neointimal thickness by OCT
timeFrame: At 6 months post-index procedure
Secondary outcomes:
measure: Percentage of Uncovered Struts by OCT
timeFrame: At 6 months post-index procedure
measure: Target lesion failure
timeFrame: 30 days, 6 months, 12 months post-index procedure
measure: Percentage of Malaposition Struts by OCT
timeFrame: At 6 months post-index procedure
measure: Thrombosis (from ARC definition)
timeFrame: 30 days, 6 months, 12 months post-index procedure
measure: In-stent and in-segment late lumen loss
timeFrame: At 6 months post-index procedure
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
Study officials:
References:
citation: He Y, Wang R, Liu J, Li F, Li J, Li C, Zhou J, Zhao Z, Yang W, Mou F, Wang J, Kan J, Li X, Li Y, Zheng M, Chen S, Gao C, Tao L. A Randomized Comparison of the Healing Response Between the Firehawk Stent and the Xience Stent in Patients With ST-Segment Elevation Myocardial Infarction at 6 Months of Follow-Up (TARGET STEMI OCT China Trial): An Optical Coherence Tomography Study. Front Cardiovasc Med. 2022 Jun 1;9:895167. doi: 10.3389/fcvm.2022.895167. eCollection 2022.