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Coronary Artery DiseaseNCT03284255

Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System Clinical Study

A study testing study group in people with Coronary Artery Disease and Antineoplastic Agents, run by Shanghai Bio-heart Biological Technology Co., Ltd. at 25 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
study group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
431 participants
Where
25 sitesChina
Study dates
11 Sep 2017to 30 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • subjects that participate in this study must fulfill all the following criteria:
  • general inclusion 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.
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  • Angiographic inclusion criteria:
  • 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.

Who cannot join

  • If subjects fulfill any of below criterias, this subject shall be exclude from this study.
  • general exclusion criteria:
  • 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;
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  • 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;
  • Subjects are planning to receive or are receiving long-term anticoagulation therapy, such as heparin, warfarin and so on;
  • Subjects are planning to accept selective surgery within 6 months, need to discontinue aspirin or clopidogrel;
  • 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;
  • Diagnosed or suspected liver disease (such as hepatic cirrhosis);
  • Subjects with diffuse peripheral vascular disease, cannot use 6F catheter.
  • angiographic exclusion criteria
  • these exclusion criteria apply to the target or non-target lesion(s), target or non-target vessel(s)
  • Target or non-target lesion(s) located in left main;
  • Subjects with coronary artery triple vessel lesion in LAD, LCX or RCA, all need to be treated.
  • these exclusion criteria apply to the target lesion(s) or target vessel(s)
  • Target lesion located in left main;
  • Target lesion located in the aorto-ostial of RCA (within 3 mm of the origin of the RCA);
  • Target lesion located within 3 mm of the origin of the LAD and LCX;
  • Lesion involving a bifurcation with a:
  • Side branch ≥ 2.5 mm in diameter, or
  • Side branch with diameter stenosis ≥ 50%, or
  • Side branch requiring protection guide wire, or
  • Side branch requiring pre-dilatation.
  • Anatomy proximal to or within the lesion that may affect delivery of the Bioheart or XIENCE stent, including:
  • Extreme angulation (≥ 90°) proximal to or within the target lesion, or
  • Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion, or
  • Moderate or heavy calcification proximal to or within the target lesion
  • Target lesion involves a myocardial bridge.
  • Target vessel contains thrombus as indicated in the angiographic images or IVUS.
  • 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.
  • Target vessel has been previously treated with a stent and the target lesion is within 5 mm proximal to a previously treated lesion.
  • Target lesion cannot reach the following outcomes, after the complete balloon pre-dilatation:
  • Residual (DS %) is < 40% (per visual estimation), ≤ 20% is strongly recommended;
  • TIMI Grade-3 flow (per visual estimation);
  • No angiographic complications (e.g., no-reflow, distal embolization, side branch closure)
  • No dissections NHLBI grade D-F;
  • No chest pain lasting > 5 minutes, and;
  • No ST depression or elevation lasting > 5 minutes.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • Beijing Anzhen Hospital Capital Medical University

    Beijing, Beijing Municipality

  • BeijingChao-YangHospital

    Beijing, Beijing Municipality

  • Fuwai Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • Cangzhou Central Hospital

    Cangzhou, Hebei

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • Fujian Provincial Hospital

    Fuzhou, Fujian

  • Nanfang Hospital

    Guangzhou, Guangdong

  • The Frist Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

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

    Hangzhou, Zhejiang

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, The Inner Mongolia Autonomous Region

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Liaocheng People's Hospital

    Liaocheng, Shandong

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi

  • Shanghai Dongfang Hospital

    Shanghai, Shanghai Municipality

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality

  • Tangshan Gongren Hospital

    Tangshan, Hebei

  • Taida International Cardioascular Hospital

    Tianjin, Tianjin Municipality

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Tangdu Hospital-Fourth Military Medical University

    Xi’an, Shanxi

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • Zhongshan People's Hospital

    Zhongshan, Gunagdong

Other trials in China

About this study

Official title: A Randomized Controlled Trial of the Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in Patients With Coronary Artery Disease: BIOHEART-II

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.

Read the 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.

Being tested
study group, control group
Keywords
Bioresorbable Vascular Scaffold System, Percutaneous Coronary Intervention, Cardiac Catheterization, Tomography, Optical Coherence
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • study groupDevice

    Also called BioheartRapamycin Drug-Eluting Bioresorbable Coronary Stent System

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

  • control groupDevice

    Also called Drug Eluting Stent of Abbott's XIENCE PRIME™ or XIENCE V®

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

Study groups in NCT03284255
Study groupRoleWhat they receive
study groupExperimentalin this group the subject will accept the treatment of BioheartRapamycin Drug-Eluting Bioresorbable Coronary Stent System
Receives: Device: study group
control groupActive comparatorin this group the subject will accept the treatment of Drug Eluting Stent of Abbott's XIENCE PRIME™ or XIENCE V®
Receives: Device: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year post procedure

  2. neointima coverage percentage of stent strut (%)

    only in OCT subgroup

    Measured: 1 year post procedure

Secondary outcomes (11)

  1. device success

    defined as attainment of residual stenosis less than 30% by visual estimation and TIMI flow grade 3 post stent implantation

    Measured: immediately post procedure

  2. lesion success

    defined as attainment of diameter residual stenosis less than 30% by visual estimation and TIMI flow grade 3, after the target lesion treated by any PCI methods

    Measured: immediately post procedure

  3. clinical success

    defined as attainment of lesion success and without any major adverse cardiac events during hospitalization (up to 7 days after proceduce)

    Measured: at 1 month post procedure

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

    defined as Cardiac Death, target vessel - myocardial infarction (TV-MI), and ischemic driven - target lesion revascularization (ID-TLR)

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

  5. Patient oriented composite endpoint (PoCE)

    defined as all caused death, any myocardial infarction, and any revascularization.

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

  6. death

    cardiac death, vascular death, non-cardiovascular death

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

  7. myocardial infarction (MI)

    target vessel MI, non-target vessel MI

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

  8. target lesion revascularization

    ischemic driven, non-ischemic driven

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

  9. target vessel revascularization

    ischemic driven, non-ischemic driven

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

  10. any coronary revascularization

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

  11. ARC--defined stent thrombosis

    timing (acute, subacute, late and very late stent thrombosis); relationship (definite, probable and possible stent thrombosis)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2017
  2. Study start11 Sep 2017
  3. Primary completion30 Aug 2020 (estimated)
  4. Study completion30 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
431 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03284255
Sponsor's protocol ID
BXA2017001
Status last verified
Nov 2019
First submitted
27 Aug 2017
Last updated
21 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39814492

Questions about this trial

What is this clinical trial studying?

A study testing study group in people with Coronary Artery Disease and Antineoplastic Agents, run by Shanghai Bio-heart Biological Technology Co., Ltd. at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

in segment late luminal loss (time frame: 1 year post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03284255, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.

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