- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04150016
In-stent Repair and Vessel Reaction of STEMI Patients With OCT
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tao Ling, Doctor
- Phone Number: 15002955798
- Email: lingtao@fmmu.edu.cn
Study Locations
-
-
Shanxi
-
Xi'an, Shanxi, China
- Recruiting
- Xijing Hospital
-
Contact:
- Tao Ling, Doctor
- Email: lingtao@fmmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Firehawk implantation
22 subjects will be enrolled to receive Firehawk™ sirolimus target-eluting stent(s).
|
Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a nonsurgical procedure that improves blood flow to your heart.PCI requires cardiac catheterization, which is the insertion of a catheter tube and injection of contrast dye, usually iodine-based, into your coronary arteries.
Doctors use PCI to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque.
PCI may be used to relieve symptoms of coronary heart disease or to reduce heart damage during or after a heart attack.
Other Names:
|
Active Comparator: XIENCE implantation
22 subjects will be enrolled to receive XIENCE™ everolimus target-eluting stent(s).
|
Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a nonsurgical procedure that improves blood flow to your heart.PCI requires cardiac catheterization, which is the insertion of a catheter tube and injection of contrast dye, usually iodine-based, into your coronary arteries.
Doctors use PCI to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque.
PCI may be used to relieve symptoms of coronary heart disease or to reduce heart damage during or after a heart attack.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neointimal thickness by OCT
Time Frame: At 6 months post-index procedure
|
At 6 months post-index procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Uncovered Struts by OCT
Time Frame: At 6 months post-index procedure
|
At 6 months post-index procedure
|
Target lesion failure
Time Frame: 30 days, 6 months, 12 months post-index procedure
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30 days, 6 months, 12 months post-index procedure
|
Percentage of Malaposition Struts by OCT
Time Frame: At 6 months post-index procedure
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At 6 months post-index procedure
|
Thrombosis (from ARC definition)
Time Frame: 30 days, 6 months, 12 months post-index procedure
|
30 days, 6 months, 12 months post-index procedure
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In-stent and in-segment late lumen loss
Time Frame: At 6 months post-index procedure
|
At 6 months post-index procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XijingH-OCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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