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

A Prospective, Open Label, Multi-center Trial of Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s) by Optical Coherent Tomography (OCT) and Coronary Angiography

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Percutaneous Coronary Intervention; Drug-Eluting Stents; Tomography, Optical Coherence
• Intervention / Treatment: Device: Firehawk sirolimus target eluting coronary stent system; Device: XIENCE Everolimus-Eluting Coronary Stent System

Detailed Description

This study will recruit 196 subjects with total coronary occlusion lesion(s) in coronary arteries ≥2.25 mm to ≤4.0 mm in diameter and ≤100 mm in length (by visual estimate) in no more than 10 research centers in China. All participants met the inclusion criteria will be 1:1 randomized to receive Firehawk™ sirolimus target-eluting coronary stent or XIENCE everolimus-eluting coronary stent.

Optical Coherent Tomography (OCT) sub study: the first 44 consecutive subjects who consented to participate in the OCT sub study will undergo OCT assessment at 3 months and 12 months post index procedure. The OCT sub study will be performed in 3-5 pre-selected sites. The clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months,and 2-5 years post-index procedure.The primary endpoint is in-stent late lumen loss at 12 months post-index procedure.The secondary endpoint is neo-intimal thickness by Optical Coherent Tomography (OCT) at 3 months post-index procedure.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • The General Hospital of Shenyang Military

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Clinical Inclusion Criteria:

• 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);
• CI6. Left ventricular ejection fraction (LVEF) within 60 days ≥ 35%; Exclusion Criteria;
• CI7. Subject is willing to comply with all protocol-required follow-up evaluation.

Angiographic Inclusion Criteria (visual estimate):

• 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;

Clinical Exclusion Criteria:

• 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;
• CE11. Subjects plan to undergo PCI or CABG after the baseline PCI;
• CE12. Subjects have any coronary endovascular brachytherapy treatment previously;
• CE13. Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thiophenepyridine or aspirin);
• CE14. Subjects are suffering from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 18 months;
• CE15. Subjects are currently abusing drugs (such as alcohol, cocaine, heroin, etc);
• CE16. Subject plan to undergo any operations that may lead to confuse with the programme;
• CE17. Subjects were participating in another study of drug or medical device which did not meet its primary endpoint;
• CE18. Subjects plan to pregnant within 18 months after baseline;
• CE19. Subjects are pregnant or breastfeeding women.

Angiographic Exclusion Criteria (visual estimate):

• AE1. Target lesions with the following criteria: left main, saphenous vein grafts or arterial grafts, via saphenous vein grafts or arterial graft, and in-stent stenosis;
• AE2. Subjects with unprotected left main coronary artery disease (diameter stenosis >50%);
• AE3. Subjects have a protected left main coronary artery disease (diameter stenosis> 50% and left coronary artery bypass surgery), as well as target lesions located in the LAD and LCX;
• AE4. Subjects with other lesions of clinical significance, may be need intervention within 18 months after baseline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Firehawk implantation; 98 subjects will be enrolled to receive a test device (Firehawk™).	Device: Firehawk sirolimus target eluting coronary stent system; 98 subjects will be enrolled to receive a test device of Firehawk sirolimus target eluting coronary stent system; Other Names: Firehawk™
Active Comparator: XIENCE implantation; 98 subjects will be enrolled to receive a control device (XIENCE).	Device: XIENCE Everolimus-Eluting Coronary Stent System; 98 subjects will be enrolled to receive a control device of XIENCE Everolimus-Eluting Coronary Stent System; Other Names: XIENCE EES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-stent late lumen loss	At 12 months post-index procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Neo-intimal thickness by Optical Coherence Tomography (OCT)	At 3 months post-index procedure

Other Outcome Measures

Outcome Measure	Time Frame
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.
Target Lesion Revascularization (TLR)	During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI)	During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
Death (All cause, Cardiac, Non-cardiac)	During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
Cardiac Death/ All Myocardial Infarction	During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
Stent Thrombosis (per ARC definition)	During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
In-stent and in-segment percent diameter stenosis (DS%)	At 12 months post-index procedure.
In-segment late lumen loss	At 12 months post-index procedure.
In-stent and in-segment minimum lumen diameter (MLD)	At 12 months post-index procedure.
In-stent and in-segment binary restenosis rate (%)	At 12 months post-index procedure.
Mean/Minimal Stent area (mm2)	At 3 months and 12 months post-index procedure.
Mean/Minimal Lumen area (mm2)	At 3 months and 12 months post-index procedure.
Lumen volume (mm3)	At 3 months and 12 months post-index procedure.
Stent volume (mm3)	At 3 months and 12 months post-index procedure.
Mean neointimal hyperplasia area (mm2)	At 3 months and 12 months post-index procedure.
In-stent neointimal hyperplasia volume obstruction (%)	At 3 months and 12 months post-index procedure.
Uncovered strut rate (%)	At 3 months and 12 months post-index procedure.
Malapposed strut rate (%)	At 3 months and 12 months post-index procedure.
Malposed and uncovered strut rate (%)	At 3 months and 12 months post-index procedure.
Technical success rate	Instantly after index procedure.
Clinical procedural success rate	At time of procedure up to 7 days in hospital.

Collaborators and Investigators

• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
• Investigators: Principal Investigator: Yaling Han, MD, The General Hospital of Shenyang Military

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2017
• Primary Completion (Actual): September 16, 2019
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Everolimus; Sirolimus
• Other Study ID Numbers: TARGET CTO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Additionally, study protocol will be available. The data will become available for the beginning 3 months and ending 5 years following article publication. The access criteria are as follow:

(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).

If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.

• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No