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

Percutaneous Coronary Intervention Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03040934
• Other study ID #: TARGET CTO
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: October 2023

Study information

• Verified date: January 2020
• Source: Shanghai MicroPort Medical (Group) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 196
• Est. completion date: October 2023
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	The General Hospital of Shenyang Military	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai MicroPort Medical (Group) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Target Vessel Failure (TVF)		During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
Other	Target Lesion Failure (TLF)		During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
Other	Target Vessel Revascularization (TVR)		During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
Other	Target Lesion Revascularization (TLR)		During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
Other	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.
Other	Death (All cause, Cardiac, Non-cardiac)		During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
Other	Cardiac Death/ All Myocardial Infarction		During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
Other	Stent Thrombosis (per ARC definition)		During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
Other	In-stent and in-segment percent diameter stenosis (DS%)		At 12 months post-index procedure.
Other	In-segment late lumen loss		At 12 months post-index procedure.
Other	In-stent and in-segment minimum lumen diameter (MLD)		At 12 months post-index procedure.
Other	In-stent and in-segment binary restenosis rate (%)		At 12 months post-index procedure.
Other	Mean/Minimal Stent area (mm2)		At 3 months and 12 months post-index procedure.
Other	Mean/Minimal Lumen area (mm2)		At 3 months and 12 months post-index procedure.
Other	Lumen volume (mm3)		At 3 months and 12 months post-index procedure.
Other	Stent volume (mm3)		At 3 months and 12 months post-index procedure.
Other	Mean neointimal hyperplasia area (mm2)		At 3 months and 12 months post-index procedure.
Other	In-stent neointimal hyperplasia volume obstruction (%)		At 3 months and 12 months post-index procedure.
Other	Uncovered strut rate (%)		At 3 months and 12 months post-index procedure.
Other	Malapposed strut rate (%)		At 3 months and 12 months post-index procedure.
Other	Malposed and uncovered strut rate (%)		At 3 months and 12 months post-index procedure.
Other	Technical success rate		Instantly after index procedure.
Other	Clinical procedural success rate		At time of procedure up to 7 days in hospital.
Primary	In-stent late lumen loss		At 12 months post-index procedure
Secondary	Neo-intimal thickness by Optical Coherence Tomography (OCT)		At 3 months post-index procedure