Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s)

NCT03040934 | Unknown DMC

• 1 other identifier: TARGET CTO
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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).

Conditions

Drug-Eluting Stents; Percutaneous Coronary Intervention; Tomography, Optical Coherence

Outcome Measures

Primary Outcomes (1)

• In-stent late lumen loss

  At 12 months post-index procedure

Secondary Outcomes (1)

• Neo-intimal thickness by Optical Coherence Tomography (OCT)

  At 3 months post-index procedure

Other Outcomes (23)

• 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.

Study Arms (2)

Firehawk implantation

ACTIVE COMPARATOR

98 subjects will be enrolled to receive a test device (Firehawk™).

Device: Firehawk sirolimus target eluting coronary stent system

XIENCE implantation

ACTIVE COMPARATOR

98 subjects will be enrolled to receive a control device (XIENCE).

Device: XIENCE Everolimus-Eluting Coronary Stent System

Interventions

Firehawk sirolimus target eluting coronary stent system DEVICE

98 subjects will be enrolled to receive a test device of Firehawk sirolimus target eluting coronary stent system

Also known as: Firehawk™

Firehawk implantation

XIENCE Everolimus-Eluting Coronary Stent System DEVICE

98 subjects will be enrolled to receive a control device of XIENCE Everolimus-Eluting Coronary Stent System

Also known as: XIENCE EES

XIENCE implantation

Eligibility Criteria

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

You may qualify if:

• CI1. Subject must be at least 18 years of age;
• 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;
• CI3. Subject is eligible for percutaneous coronary intervention (PCI);
• CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
• CI5. Subjects are eligible candidates for coronary artery bypass graft surgery (CABG);

You may not qualify if:

• CI7. Subject is willing to comply with all protocol-required follow-up evaluation.
• AI1. Target lesions must be new and have a visually estimated reference diameter ≥2.25 mm and ≤4.0 mm in autologous coronary artery;
• AI2. Target lesions must be \< 100 mm in length (visual estimate) and the number of implanted stents is less than 4;
• AI3. Target lesions must be visually complete occlusion and longer than 4 weeks;
• AI4. Target lesions must be able to pass and be successfully expanded;
• 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;
• CE2. Subjects had an organ transplant or are waiting for an organ transplant;
• CE3. Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days after PCI;
• CE4. Subjects are undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome;
• 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;
• CE6. Subjects have confirmed or suspected liver disease, including hepatitis lab results;
• CE7. Subjects with elevated serum creatinine level \>3.0mg/dL or undergoing dialysis therapy;
• CE8. Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion;
• CE9. Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months, or with permanent nerve defects;
• 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;

Sponsors & Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.: lead

Study Sites (1)

The General Hospital of Shenyang Military

Shenyang, Liaoning, China

Location

Related Publications (2)

• Wang G, Zhang R, Chen SL, Wang J, Li Y, Zheng M, Cao R, Ma Y, Sun Z, Li X, Su X, Lu W, Xu Y, Li X, Li Y, Sun F, Han Y; TARGET CTO Investigators. Targeted therapy with a localized abluminal groove low-dose sirolimus-eluting bioabsorbable polymer coronary stent in chronic total occlusions: The TARGET CTO non-inferiority randomized trial. Am Heart J. 2025 Jul;285:93-104. doi: 10.1016/j.ahj.2025.01.018. Epub 2025 Feb 3.

  PMID: 39909342 DERIVED

• Wang G, Li Y, Lu W, Xu Y, Su X, Chen S, Li Y, Han Y; TARGET CTO OCT substudy Investigators. Vascular Healing After Biodegradable Polymer Sirolimus-Eluting Versus Durable Polymer Everolimus-Eluting Stents in Chronic Total Occlusions. Catheter Cardiovasc Interv. 2025 Apr;105(5):1124-1133. doi: 10.1002/ccd.31423. Epub 2025 Jan 29.

  PMID: 39878429 DERIVED

Study Officials

• Yaling Han, MD

  The General Hospital of Shenyang Military

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 2, 2017
• Study Start: November 10, 2017
• Primary Completion: September 16, 2019
• Study Completion: October 1, 2023
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: (With) Researchers who provide a methodologically sound proposal. (For the analysis) to achieve aims in the approved proposal. (Requisite mechanism) Proposals should be directed to mzheng@microport.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).

Locations

CN (1)