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Coronary Artery DiseaseNCT04179045

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

A study testing The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in people with Coronary Artery Disease, run by Shanghai Bio-heart Biological Technology Co., Ltd. at 5 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
785 participants
Where
5 sitesChina
Study dates
1 Mar 2021to Jul 2026
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

  • 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, 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.
  • Angiographic Inclusion Criteria:
Show all 12Show fewer
  • 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.

Who cannot join

  • 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 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.
Show all 47Show fewer
  • 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.
  • Blood tests showed that the platelet count is less than 100 × 10^9 / L, or more than 700 × 10^9 / L, the white blood cells count is less than 3 × 10^9 /L.
  • subject with diagnosed or suspected liver cirrhosis.
  • Subjects with diffuse peripheral vascular disease, that precludes safe 6 French sheath insertion.
  • 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 triple vessel lesion in LAD, LCX or RCA, which 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, 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 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 meet 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

5 sites in 1 country.

Guosheng Fu, Professor contact

0086-0571-86006246

fugs@medmail.com

5 sites in 1 country

China5 sites

  • Beijing Anzhen Hospital Capital Medical University

    Beijing, Beijing Municipality

    chengjun Guo, Professor, spnie@126.com

    Chengjun Guo, professor

  • BeijingChao-YangHospital

    Beijing, Beijing Municipality

    Lefeng Wang, professor, wlf311@126.com

  • Nanfang Hospital

    Guangzhou, Guangdong

    Yuqing Hou, Professor, hyq@fimmu.com

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

    Hangzhou, Zhejiang

    Guosheng Fu, Professor, 0086- 0571-86006246, fugs@medmail.com

  • Taida International Cardioascular Hospital

    Tianjin, Tianjin Municipality

    Feng Zhang, Professor, zfwh909@aliyun.com

Other trials in China

About this study

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

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.

Being tested
The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
Keywords
Bioresorbable Vascular Scaffold System, Percutaneous Coronary Intervention
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.

  • The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent SystemDevice

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

Study groups in NCT04179045
Study groupRoleWhat they receive
BioheartExperimentalSubjects 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.
Receives: Device: The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System

What is being measured

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

  1. TLF

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

    Measured: 1 year after index procedure

Secondary outcomes (6)

  1. The device-oriented composite（DoCE） / TLF

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

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

  2. The patient-oriented composite（PoCE）

    includes all-cause mortality, any MI, and any revascularization. Death（Cardiac death，Vascular death，Non-cardiovascular death）; Myocardial Infarction (target vessel MI, non-target vessel MI); Target lesion Revascularization（ischemic driven, non-ischemic driven） target vessel Revascularization （ischemic driven, non-ischemic driven）; Any Revascularization （ischemic driven, non-ischemic driven）.

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

  3. Stent Thrombosis（ARC）

    Timing：Acute, Subacute, Late,Very late stent thrombosis Definite and Probable Stent Thrombosis

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

  4. Device success

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

    Measured: immediately after index procedure

  5. 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 after index procedure

  6. Clinical success

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

    Measured: up to 7 days after index procedure

Timeline

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

  1. First posted26 Nov 2019
  2. Study start1 Mar 2021 (estimated)
  3. Primary completionJul 2022 (estimated)
  4. Study completionJul 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
785 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04179045
Sponsor's protocol ID
BXA 2019001
Status last verified
Feb 2021
First submitted
18 Nov 2019
Last updated
26 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in people with Coronary Artery Disease, run by Shanghai Bio-heart Biological Technology Co., Ltd. at 5 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 12 inclusion and 47 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 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Contact Guosheng Fu, Professor (0086-0571-86006246, fugs@medmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TLF (time frame: 1 year after index procedure). 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 NCT04179045.

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 26 Feb 2021.

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