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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-10

Study Completion Date

2023-10-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Drug-Eluting Stents Percutaneous Coronary Intervention Tomography, Optical Coherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Firehawk implantation

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

Group Type ACTIVE_COMPARATOR

Firehawk sirolimus target eluting coronary stent system

Intervention Type DEVICE

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

XIENCE implantation

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

Group Type ACTIVE_COMPARATOR

XIENCE Everolimus-Eluting Coronary Stent System

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

XIENCE Everolimus-Eluting Coronary Stent System

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

Intervention Type DEVICE

Other Intervention Names

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Firehawk™ XIENCE EES

Eligibility Criteria

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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);

* 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;

Exclusion Criteria

* CI7. Subject is willing to comply with all protocol-required follow-up evaluation.

* 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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No