Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System Clinical Study

NCT03284255 | Unknown

• 1 other identifier: BXA2017001
• Study Type: interventional
• Target: 431
• Locations: 1 country
• Sites: 25

Brief Summary

The Bioheart Randomized Controlled Trial is a prospective multicentred paralleled study, which will enroll 430 patients and randomized 1:1 to study group and control group. Aim to assess the efficacy and safety of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System compare with XIENCE stent in the treatment of patients with up to two coronary lesions.

Conditions

Coronary Artery Disease; Antineoplastic Agents

Keywords

Bioresorbable Vascular Scaffold System; Percutaneous Coronary Intervention; Cardiac Catheterization; Tomography, Optical Coherence

Outcome Measures

Primary Outcomes (2)

• in segment late luminal loss

  In-segment late loss is defined as the change in minimal lumen diameter (MLD) from post-procedure to 1 year by angiography，in segment is defined within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.

  1 year post procedure

• neointima coverage percentage of stent strut (%)

  only in OCT subgroup

  1 year post procedure

Secondary Outcomes (11)

• device success

  immediately post procedure

• lesion success

  immediately post procedure

• clinical success

  at 1 month post procedure

• Device oriented composite endpoint (DoCE)/target lesion failure (TLF)

  at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure

• Patient oriented composite endpoint (PoCE)

  at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure

Other Outcomes (10)

• angiographic endpoints-acute stent recoil

  immediately post procedure

• angiographic endpoints-late lumen loss (LLL)

  immediately and 1 year post procedure

• angiographic endpoints-minimal lumen diameter (MLD)

  immediately and 1 year post procedure

Study Arms (2)

study group

EXPERIMENTAL

in this group the subject will accept the treatment of BioheartRapamycin Drug-Eluting Bioresorbable Coronary Stent System

Device: study group

control group

ACTIVE COMPARATOR

in this group the subject will accept the treatment of Drug Eluting Stent of Abbott's XIENCE PRIME™ or XIENCE V®

Device: control group

Interventions

study group DEVICE

study group in which patient will accept the treatment of Bioresorbable Coronary Stent

Also known as: BioheartRapamycin Drug-Eluting Bioresorbable Coronary Stent System

study group

control group DEVICE

control group in which patient will accept the treatment of Drug Eluting Stent of Abbott's XIENCE PRIME™ or XIENCE V®

Also known as: Drug Eluting Stent of Abbott's XIENCE PRIME™ or XIENCE V®

control group

Eligibility Criteria

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

You may qualify if:

• subjects that participate in this study must fulfill all the following criteria:
• 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, 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, willing to accept invasive imaging follow-up.
• One or two de novo target lesions
• If subject has only one target lesion, the second non-target lesion can be treated but this non-target lesion must locate in a different epicardial vessel, and must be treated first and be treated successfully prior to the subjects' randomization.
• If there are two target lesions, they must locate in different epicardial vessels and both satisfy the angiographic eligibility criteria.
• 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 diagonal branch
• Target lesion diameter stenosis ≥ 70% (or ≥ 50% simultaneously shall have clinical evidence of myocardial ischemia), and TIMI flow grade ≥1; Target lesion length ≤24mm (visually); target lesion diameter between ≥ 2.5 mm to ≤ 4.00 mm.
• Each target lesion can be fully covered by one stent.

You may not qualify if:

• If subjects fulfill any of below criterias, this subject shall be exclude from this study.
• Any newly onset acute myocardial infarction within 1 week or, myocardial enzymes does not return to normal level after myocardial infarction;
• Target lesion has any stents implant history within 1 year or subjects planning to receive percutaneous artery intervention within half one year;
• Subjects with severe heart failure (≥ grade III NYHA) or left ventricular ejection fraction \<35% (accessed by ultrasound or left ventricular angiography)
• Preprocedure severe kidney functional damaged: serum creatinine\> 2.0mg /dl (176.8μmol / L) or subject is receiving hemodialysis;
• Subjects with bleeding tendency, active gastrointestinal ulcers, history of cerebral hemorrhage or history of subarachnoid hemorrhage, history within six months of ischemic stroke, contraindications of anti-platelet agents and anticoagulants treatment, and subjects cannot receive anti-thrombolytic therapy;
• Hypersensitive or allergic to aspirin, clopidogrel, heparin, contrast agent, polylactic acid polymer， rapamycin;
• The subject's life expectancy is less than 24 months;
• Subjects participated in other drug or medical device clinical trial and have not reach the primary endpoint;
• Investigators determine the subjects' compliance is poor, cannot complete the study as required;
• Subjects have accepted substantial organ transplant or ready to undergo organ transplant;
• Subjects have unstable arrhythmia, such as high-risk ventricular premature beats, and ventricular tachycardia;
• Subjects need to receive chemotherapy because of tumor;
• Subjects have received or planning to receive coronary or chest radiotherapy;
• Subjects with Immunosuppressive, autoimmune diseases, are planned or undergoing immunosuppressive therapy;

Sponsors & Collaborators

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

Study Sites (25)

Beijing Anzhen Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

BeijingChao-YangHospital

Beijing, Beijing Municipality, China

Location

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Fujian Provincial Hospital

Fuzhou, Fujian, China

Location

Nanfang Hospital

Guangzhou, Guangdong, China

Location

The Frist Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Location

Zhongshan People's Hospital

Zhongshan, Gunagdong, China

Location

Cangzhou Central Hospital

Cangzhou, Hebei, China

Location

Tangshan Gongren Hospital

Tangshan, Hebei, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Liaocheng People's Hospital

Liaocheng, Shandong, China

Location

Shanghai Dongfang Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Location

Tangdu Hospital-Fourth Military Medical University

Xi’an, Shanxi, China

Location

Inner Mongolia Autonomous Region People's Hospital

Hohhot, The Inner Mongolia Autonomous Region, China

Location

Taida International Cardioascular Hospital

Tianjin, Tianjin Municipality, China

Location

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

Hangzhou, Zhejiang, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Related Publications (1)

• Liu S, Nie S, Hou Y, Huang G, Fu G, Zhou H, Wei M, Lu F, Zhang F, Wang L, Wang Y, Wu Y, Qiao S; BIOHEART-II Investigators. A Randomized Comparison of Bioheart Sirolimus-Eluting Bioresorbable Scaffold and Everolimus-Eluting Stents: The BIOHEART-II Trial. JACC Cardiovasc Interv. 2025 Jan 13;18(1):15-27. doi: 10.1016/j.jcin.2024.09.043.

  PMID: 39814492 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Shubin Qiao, professor

  Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

  PRINCIPAL INVESTIGATOR

• Bo Xu, professor

  Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: August 27, 2017
• First Posted: September 15, 2017
• Study Start: September 11, 2017
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2024
• Last Updated: November 21, 2019

Record last verified: 2019-11

Locations

CN (25)