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

• ClinicalTrials.gov Identifier: NCT03040934
• Recruitment Status: Active, not recruiting
• First Posted: February 2, 2017
• Last Update Posted: January 10, 2020
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
• Information provided by (Responsible Party): Shanghai MicroPort Medical (Group) Co., Ltd.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Drug-Eluting Stents; Percutaneous Coronary Intervention; Tomography, Optical Coherence	Device: Firehawk sirolimus target eluting coronary stent system; Device: XIENCE Everolimus-Eluting Coronary Stent System	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 196 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: November 10, 2017
• Actual Primary Completion Date: September 16, 2019
• Estimated Study Completion Date: October 2023

Arms and Interventions

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 Name: 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 Name: XIENCE EES

Outcome Measures

Primary Outcome Measures :

1. In-stent late lumen loss [ Time Frame: At 12 months post-index procedure ]

Secondary Outcome Measures :

1. Neo-intimal thickness by Optical Coherence Tomography (OCT) [ Time Frame: At 3 months post-index procedure ]

Other Outcome Measures:

1. Target Vessel Failure (TVF) [ Time Frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. ]
2. Target Lesion Failure (TLF) [ Time Frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. ]
3. Target Vessel Revascularization (TVR) [ Time Frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. ]
4. Target Lesion Revascularization (TLR) [ Time Frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. ]
5. Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI) [ Time Frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. ]
6. Death (All cause, Cardiac, Non-cardiac) [ Time Frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. ]
7. Cardiac Death/ All Myocardial Infarction [ Time Frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. ]
8. Stent Thrombosis (per ARC definition) [ Time Frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure. ]
9. In-stent and in-segment percent diameter stenosis (DS%) [ Time Frame: At 12 months post-index procedure. ]
10. In-segment late lumen loss [ Time Frame: At 12 months post-index procedure. ]
11. In-stent and in-segment minimum lumen diameter (MLD) [ Time Frame: At 12 months post-index procedure. ]
12. In-stent and in-segment binary restenosis rate (%) [ Time Frame: At 12 months post-index procedure. ]
13. Mean/Minimal Stent area (mm2) [ Time Frame: At 3 months and 12 months post-index procedure. ]
14. Mean/Minimal Lumen area (mm2) [ Time Frame: At 3 months and 12 months post-index procedure. ]
15. Lumen volume (mm3) [ Time Frame: At 3 months and 12 months post-index procedure. ]
16. Stent volume (mm3) [ Time Frame: At 3 months and 12 months post-index procedure. ]
17. Mean neointimal hyperplasia area (mm2) [ Time Frame: At 3 months and 12 months post-index procedure. ]
18. In-stent neointimal hyperplasia volume obstruction (%) [ Time Frame: At 3 months and 12 months post-index procedure. ]
19. Uncovered strut rate (%) [ Time Frame: At 3 months and 12 months post-index procedure. ]
20. Malapposed strut rate (%) [ Time Frame: At 3 months and 12 months post-index procedure. ]
21. Malposed and uncovered strut rate (%) [ Time Frame: At 3 months and 12 months post-index procedure. ]
22. Technical success rate [ Time Frame: Instantly after index procedure. ]
23. Clinical procedural success rate [ Time Frame: At time of procedure up to 7 days in hospital. ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

China, Liaoning

The General Hospital of Shenyang Military

Shenyang, Liaoning, China

Sponsors and Collaborators

Shanghai MicroPort Medical (Group) Co., Ltd.

Investigators

• Principal Investigator: Yaling Han, MD; The General Hospital of Shenyang Military

More Information

• Responsible Party: Shanghai MicroPort Medical (Group) Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03040934
• Other Study ID Numbers: TARGET CTO
• First Posted: February 2, 2017
• Last Update Posted: January 10, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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.

• Supporting Materials: 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).

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Sirolimus; Everolimus; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antifungal Agents