A Registry Trial of The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

NCT04179045 | Not Yet Recruiting

• 1 other identifier: BXA 2019001
• Study Type: interventional
• Target: 785
• Locations: 1 country
• Sites: 5

Brief Summary

This study is a prospective, multi-center single arm registry trial, planning to enroll 785 subjects. All subjects will receive clinical follow-up at 1 month, 6 month, 9 month and 1, 2, 3, 4, 5 year after index procedure. The primary endpoint will be target lesion failure (TLF) at 1 year after index procedure,which will be analyzed to evaluate the efficacy and safety of the device.

Conditions

Coronary Artery Disease

Keywords

Bioresorbable Vascular Scaffold System; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• TLF

  Target lesion failure, consists of cardiac death, MI attributed to the target vessel, and ischemic driven - target lesion revascularization (ID-TLR).

  1 year after index procedure

Secondary Outcomes (6)

• The device-oriented composite（DoCE） / TLF

  at 1, 6, 9 month and 1, 2, 3, 4, 5 year after index procedure

• The patient-oriented composite（PoCE）

  at 1, 6, 9 month and 1, 2, 3, 4, 5 year after index procedure

• Stent Thrombosis（ARC）

  at 1, 6, 9 month and 1, 2, 3, 4, 5 year after index procedure

• Device success

  immediately after index procedure

• Lesion success

  immediately after index procedure

Study Arms (1)

Bioheart

EXPERIMENTAL

Subjects have CAD with one or two de novo native coronary artery lesions and will be treated with Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System. There will be only one arm in this study.

Device: The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

Interventions

The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System DEVICE

Subjects enrolled will be treated with Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent.

Bioheart

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 75 years old, man or non-pregnant woman.
• Subjects with asymptomatic ischemic evidence, stable or unstable angina, or old myocardial infarction, are suitable for selective PCI.
• Subjects without contraindications of coronary artery bypass grafting (CABG).
• Subjects are able to understand the purpose of this study, volunteer to participate and sign informed consent.
• One or two de novo target lesions
• If subject has only one target lesion, the second non-target lesion must be treated but the non-target lesion must be present in a different epicardial vessel; the non target lesion must be treated first and successfully prior to the subjects' register.
• If there are two target lesions, they must be present in different epicardial vessels.
• The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a branch.
• Target lesion diameter stenosis is estimated visually ≥ 70% (or ≥ 50% with clinical evidence of myocardial ischemia), with TIMI flow grade ≥1; Target lesion length ≤24mm (visually); target lesion diameter between ≥2.5 mm to ≤ 4.00 mm.
• Each target lesion must be covered completely by one scaffold.

You may not qualify if:

• Any newly onset acute myocardial infarction within 1 week or, myocardial enzymes does not return to normal level after myocardial infarction.
• Target vessel has been implanted with stents within 1 year before procedure.
• Subjects with severe heart failure (≥ grade III NYHA) or left ventricular ejection fraction \<35% (accessed by ultrasound or left ventricular angiography).
• subject with severe kidney functional damaged before procedure: serum creatinine\>2.0mg /dl (176.8μmol / L) or subject is receiving hemodialysis.
• Subjects with high bleeding risk, with active gastrointestinal ulcers, history of cerebral hemorrhage or history of subarachnoid hemorrhage, history of ischemic stroke within the past six months, with contraindications of anti-platelet agents and anticoagulants, and subjects cannot receive antithrombolytic therapy.
• subject is known hypersensitive or allergic to aspirin, clopidogrel, heparin, contrast agent, polylactic acid polymer and rapamycin.
• The subject's life expectancy is less than 24 months.
• Subjects is currently participating in other drug or medical device clinical trial that has not yet completed its primary endpoint .
• Subjects have received any solid organ transplants or are ready to undergo organ transplant.
• Subjects have unstable arrhythmia, such as high-risk ventricular premature beats, and ventricular tachycardia.
• Subjects receive chemotherapy for tumor.
• Subjects have received or planning to receive coronary or chest radiotherapy.
• Subjects with Immunosuppressive, autoimmune diseases, have planned to receive or underwent immunosuppressive therapy.
• Subjects have planned to receive or are receiving long-term anticoagulation therapy, such as heparin, warfarin and so on.
• Subjects have planned to receive selective surgery within 6 months, which requires them to discontinue aspirin or clopidogrel.

Sponsors & Collaborators

• Shanghai Bio-heart Biological Technology Co., Ltd.: lead
• CCRF Inc., Beijing, China: collaborator

Study Sites (5)

Beijing Anzhen Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

BeijingChao-YangHospital

Beijing, Beijing Municipality, China

Location

Nanfang Hospital

Guangzhou, Guangdong, China

Location

Taida International Cardioascular Hospital

Tianjin, Tianjin Municipality, China

Location

Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang UniversitySchool of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Guosheng Fu, Professor

  Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guosheng Fu, Professor

CONTACT

0086-0571-86006246; fugs@medmail.com

Study Design

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

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 26, 2019
• Study Start: March 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2026
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

CN (5)