In-stent Repair and Vessel Reaction of STEMI Patients With OCT

NCT04150016 | Unknown

• 1 other identifier: XijingH-OCT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Drug-eluting Stents; Percutaneous Coronary Intervention; Optical Coherence Tomography; ST-Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Neointimal thickness by OCT

  At 6 months post-index procedure

Secondary Outcomes (5)

• Percentage of Uncovered Struts by OCT

  At 6 months post-index procedure

• Target lesion failure

  30 days, 6 months, 12 months post-index procedure

• Percentage of Malaposition Struts by OCT

  At 6 months post-index procedure

• Thrombosis (from ARC definition)

  30 days, 6 months, 12 months post-index procedure

• In-stent and in-segment late lumen loss

  At 6 months post-index procedure

Study Arms (2)

Firehawk implantation

EXPERIMENTAL

22 subjects will be enrolled to receive Firehawk™ sirolimus target-eluting stent(s).

Procedure: percutaneous coronary intervention

XIENCE implantation

ACTIVE COMPARATOR

22 subjects will be enrolled to receive XIENCE™ everolimus target-eluting stent(s).

Procedure: percutaneous coronary intervention

Interventions

percutaneous coronary intervention PROCEDURE

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.

Also known as: PCI

Firehawk implantation; XIENCE implantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• mm elevation in more than 2 continuously leads, or; Newly developed LBBB, or;
• mm 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;
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi’an, Shanxi, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35722108 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Tao Ling, Doctor

CONTACT

15002955798; lingtao@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: March 8, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: November 4, 2019

Record last verified: 2019-10

Locations

CN (1)