Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System Clinical Study

NCT ID: NCT03284255

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 431 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2024-08-30

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.

Detailed Description

This study is a prospective, multicentred randomized controlled trial, planning to enroll 430 subjects and randomize 1:1 to study group and control group.

All subjects will accept clinical evaluation at 1 month, 6 month, 9 month and 1, 2, 3, 4, 5 year post procedure.

All subjects will accept angiographic evaluation at 1 year post procedure, and simutaneously 80 subjects (40 in study group and 40 in control group) will accepted OCT evaluation.

To assess the efficacy and safety, the primary endpoint will be in segment late luminal loss at 1 year post procedure, the secondary endpoint is neointima coverage percentage of stent strut (%) at 1 year post procedure.

Conditions

Coronary Artery Disease; Antineoplastic Agents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

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

Group Type: EXPERIMENTAL

study group

Intervention Type: DEVICE

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

control group

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

Group Type: ACTIVE_COMPARATOR

control group

Intervention Type: DEVICE

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

Interventions

study group

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

Intervention Type: DEVICE

control group

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

Intervention Type: DEVICE

Other Intervention Names

BioheartRapamycin Drug-Eluting Bioresorbable Coronary Stent System; Drug Eluting Stent of Abbott's XIENCE PRIME™ or XIENCE V®

Eligibility Criteria

Inclusion Criteria

subjects that participate in this study must fulfill all the following criteria:

1. Age from 18 to 75 years old, man or non-pregnant woman;

2. Subjects with asymptomatic ischemic evidence, stable or unstable angina, or old myocardial infarction, suitable for selective PCI;

3. Subjects without contraindications of coronary artery bypass grafting (CABG);

4. Subjects are able to understand the purpose of this study, volunteer to participate and sign informed consent, willing to accept invasive imaging follow-up.

1. One or two de novo target lesions

1. 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.

2. If there are two target lesions, they must locate in different epicardial vessels and both satisfy the angiographic eligibility criteria.

3. 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

2. 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.

3. Each target lesion can be fully covered by one stent.

Exclusion Criteria

If subjects fulfill any of below criterias, this subject shall be exclude from this study.

1. Any newly onset acute myocardial infarction within 1 week or, myocardial enzymes does not return to normal level after myocardial infarction;

2. Target lesion has any stents implant history within 1 year or subjects planning to receive percutaneous artery intervention within half one year;

3. Subjects with severe heart failure (≥ grade III NYHA) or left ventricular ejection fraction <35% (accessed by ultrasound or left ventricular angiography)

4. Preprocedure severe kidney functional damaged: serum creatinine> 2.0mg /dl (176.8μmol / L) or subject is receiving hemodialysis;

5. 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;

6. Hypersensitive or allergic to aspirin, clopidogrel, heparin, contrast agent, polylactic acid polymer， rapamycin;

7. The subject's life expectancy is less than 24 months;

8. Subjects participated in other drug or medical device clinical trial and have not reach the primary endpoint;

9. Investigators determine the subjects' compliance is poor, cannot complete the study as required;

10. Subjects have accepted substantial organ transplant or ready to undergo organ transplant;

11. Subjects have unstable arrhythmia, such as high-risk ventricular premature beats, and ventricular tachycardia;

12. Subjects need to receive chemotherapy because of tumor;

13. Subjects have received or planning to receive coronary or chest radiotherapy;

14. Subjects with Immunosuppressive, autoimmune diseases, are planned or undergoing immunosuppressive therapy;

15. Subjects are planning to receive or are receiving long-term anticoagulation therapy, such as heparin, warfarin and so on;

16. Subjects are planning to accept selective surgery within 6 months, need to discontinue aspirin or clopidogrel;

17. Blood tests showed that the platelet count is less than 100 × 109 / L, or over than 700 × 109 / L, the white blood cells count is less than 3 × 109 / L;

18. Diagnosed or suspected liver disease (such as hepatic cirrhosis);

19. Subjects with diffuse peripheral vascular disease, cannot use 6F catheter.

1. Target or non-target lesion(s) located in left main;

2. Subjects with coronary artery triple vessel lesion in LAD, LCX or RCA, all need to be treated.

1. Target lesion located in left main;

2. Target lesion located in the aorto-ostial of RCA (within 3 mm of the origin of the RCA);

3. Target lesion located within 3 mm of the origin of the LAD and LCX;

4. Lesion involving a bifurcation with a:

1. Side branch ≥ 2.5 mm in diameter, or

2. Side branch with diameter stenosis ≥ 50%, or

3. Side branch requiring protection guide wire, or

4. Side branch requiring pre-dilatation.

5. Anatomy proximal to or within the lesion that may affect delivery of the Bioheart or XIENCE stent, including:

1. Extreme angulation (≥ 90°) proximal to or within the target lesion, or

2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion, or

3. Moderate or heavy calcification proximal to or within the target lesion

6. Target lesion involves a myocardial bridge.

7. Target vessel contains thrombus as indicated in the angiographic images or IVUS.

8. Prior to the index procedure target vessel has been previously treated with a stent at any time such that the Bioheart or XIENCE stent would need to cross the stent to reach the target lesion.

9. Target vessel has been previously treated with a stent and the target lesion is within 5 mm proximal to a previously treated lesion.

10. Target lesion cannot reach the following outcomes, after the complete balloon pre-dilatation:

1. Residual (DS %) is < 40% (per visual estimation), ≤ 20% is strongly recommended;

2. TIMI Grade-3 flow (per visual estimation);

3. No angiographic complications (e.g., no-reflow, distal embolization, side branch closure)

4. No dissections NHLBI grade D-F;

5. No chest pain lasting > 5 minutes, and;

6. No ST depression or elevation lasting > 5 minutes.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CCRF Inc., Beijing, China

INDUSTRY

Sponsor Role: collaborator

Shanghai Bio-heart Biological Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shubin Qiao, professor

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

Bo Xu, professor

Role: STUDY_CHAIR

Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

Locations

Beijing Anzhen Hospital Capital Medical University

Beijing, Beijing Municipality, China

BeijingChao-YangHospital

Beijing, Beijing Municipality, China

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

Nanfang Hospital

Guangzhou, Guangdong, China

The Frist Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Zhongshan People's Hospital

Zhongshan, Gunagdong, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

Tangshan Gongren Hospital

Tangshan, Hebei, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The Second Hospital of Jilin University

Changchun, Jilin, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Shanghai Dongfang Hospital

Shanghai, Shanghai Municipality, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Tangdu Hospital-Fourth Military Medical University

Xi’an, Shanxi, China

Inner Mongolia Autonomous Region People's Hospital

Hohhot, The Inner Mongolia Autonomous Region, China

Taida International Cardioascular Hospital

Tianjin, Tianjin Municipality, China

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

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39814492 (View on PubMed)

Other Identifiers

BXA2017001

Identifier Type: -

Identifier Source: org_study_id