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Coronary Artery DiseaseFUTURE-IIINCT03660202

Trial for MicroPort's Firesorb BVS: FUTURE-III

A study testing Firesorb in people with Coronary Artery Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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 FUTURE-III study is a confirmative clinical trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) after the feasibility and safety of the device has been preliminary confirmed in a small-scale First-in-Man clinical trial. 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?
Firesorb
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteChina
Study dates
Jan 2019to Jun 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

General Inclusion Criteria:

  1. 18-75 years of age, males or non-pregnant females;
  2. With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
  3. Patients with indications for coronary artery bypass graft surgery; To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

Angiographic Inclusion Criteria:

  1. General Specification Subgroup:
  2. One or two de novo target lesions: If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria. Note: The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
  3. Target lesion(s) must be located in a native coronary artery with a visually estimated stenosis ≥ 70% or ≥ 50% and < 100% with clinical evidence of myocardial ischemia, a thrombolysis in myocardial infarction (TIMI) flow of ≥1. Target lesion vessel length ≤25mm by visual estimation, target vessel diameter 2.5mm-4.0mm.
  4. Each target lesion may be covered with one stent.
  5. Long Lesion Subgroup:
  6. One de novo target lesion.
  7. Target lesion(s) must be located in a native coronary artery with a visually estimated stenosis ≥ 70% or ≥ 50% and < 100% with clinical evidence of myocardial ischemia, a thrombolysis in myocardial infarction (TIMI) flow of ≥1. Target lesion vessel length ≤34mm by visual estimation, target vessel diameter 3.0mm-4.0mm.
  8. Each target lesion may be covered with one stent.

General Exclusion Criteria:

  1. Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
  2. Implantation of stent in target vessel within 1 year;
  3. Patients with planned intervention again within six months;
  4. Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction <40% (ultrasound or left ventricular angiography);
  5. Preoperative renal function serum creatinine >2.0mg/DL; receiving hemodialysis;
  6. Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
  7. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
  8. The patient's life expectancy is less than 12 months;
  9. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
  10. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
  11. Heart transplantation patients;
  12. The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
  13. Cancer need chemotherapy;
  14. Immunosuppression and autoimmune diseases, planned or undergoing immunosuppressive therapy;
  15. Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
  16. Within six months for elective surgery requires stopping aspirin, Clopidogrel patients;
  17. Blood test prompted platelet counts of less than 100x10E9/L or greater than 700x10E9/L, white blood cells than 3x10E9/L; known or suspected liver disease (such as hepatitis);
  18. Peripheral vascular disease, 6F catheter is not available.

Angiographic Exclusion Criteria:

  1. Left main coronary artery disease;
  2. Severe triple vessel lesion and required revascularization.

The following exclusion criteria apply to the target lesion(s) or target vessel(s):

  1. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
  2. Lesion located within 3 mm of the origin of the Left Anterior Descending Artery (LAD) or left circumflex artery (LCX).
  3. 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 guide wire, or (4)side branch requiring dilatation. 4. Anatomy proximal to or within the lesion that may impair delivery of Firesorb :
  4. Extreme angulation (≥ 90°) proximal to or within the target lesion.
  5. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
  6. Moderate or heavy calcification proximal to or within the target lesion. 5. Lesion or vessel involves a myocardial bridge. 6. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
  7. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Firesorb or XIENCE would need to cross the stent to reach the target lesion.
  8. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
  9. Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
  10. Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is strongly recommended.
  11. TIMI Grade-3 flow (per visual estimation).
  12. No angiographic complications (e.g. distal embolization, side branch closure).
  13. No dissections National Heart Lung and Blood Institute (NHLBI) grade D-F.
  14. No chest pain lasting > 5 minutes.
  15. No ST depression or elevation lasting > 5 minutes.

Trial locations and contacts

1 site in 1 country.

Bo Xu, MBBS contact

010-88322562

bxu@citmd.com

China1 site
  • Fu Wai Hospital

    Beijing, Beijing Municipality, 100037

Other trials in China

About this study

Official title: A Prospective Multicenter Single-arm Clinical Trial Assessing the Safety and Effectiveness of Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold for the Treatment of Coronary Artery Disease: FUTURE III

The FUTURE-III study is a confirmative clinical trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) after the feasibility and safety of the device has been preliminary confirmed in a small-scale First-in-Man clinical trial.

Read the detailed description

This study is a prospective, multicenter, single-arm trial in patients with coronary artery disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels. The goal is to evaluate the safety and effectiveness of Firesorb to support the approval of the Chinese Food and Drug Administration (CFDA) for this product.All subjects will undergo clinical follow-up at 1-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-index procedure. A total of 1200 subjects will be recruited, including 96 with long lesion (the scaffold to be used with a length of 33mm or 38mm) and 215 in the experimantal group of FUTURE-II clinical trial.

Being tested
Firesorb
Keywords
Bioresorbable Vascular Scaffold
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.

  • FiresorbDevice

    Implantation of Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb)

Study groups in NCT03660202
Study groupRoleWhat they receive
Single ArmExperimentalSingle Arm Safety and Effectiveness Confirmatory Study of Firesorb BVS
Receives: Device: Firesorb

What is being measured

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

  1. The number and rate of Target Lesion Failure(TLF)

    Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and ischemia-driven target lesion revascularization.

    Measured: 1 year after index procedure

Secondary outcomes (10)
  1. The number and rate of Acute Success-Device Success

    Successful delivery and deployment of the assigned scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by visual.

    Measured: From the start of index procedure to end of index procedure

  2. Acute Success-Procedural Success

    Achievement of final in-scaffold residual stenosis of less than 30% by visual estimation with successful delivery and deployment of at least one assigned scaffold at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR.

    Measured: At time of procedure up to 7 days in hospital

  3. Device-oriented composite endpoints (Target Lesion Failure)

    Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and ischemia-driven target lesion revascularization.

    Measured: 1 month,6 months,2 years,3 years,4 years and 5 years after index procedure

  4. Patient-oriented clinical composite endpoint (PoCE)

    Patient-oriented clinical composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization.

    Measured: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure

  5. Death (Cardiac, Vascular, Non-cardiovascular)

    Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions, such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

    Measured: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure

  6. The number and rate of Myocardial Infarction (MI)

    Attributable to target vessel (TV-MI), Not attributable to target vessel (NTV-MI)

    Measured: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure

  7. The number and rate of Target Vessel Revascularization (TVR)

    Ischemia-driven TVR (ID-TVR), Not ischemia-driven TVR (NID-TVR)

    Measured: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure

  8. The number and rate of Target Lesion Revascularization (TLR)

    Ischemia-driven TLR (ID-TLR), Not ischemia-driven TLR (NID-TLR)

    Measured: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure

  9. The number and rate of Any Revascularization

    Ischemia-driven , Not ischemia-driven

    Measured: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure

  10. The number and rate of Scaffold Thrombosis (per ARC definition)

    Timing (acute, sub-acute, late and very late) Evidence (Definite and Probable)

    Timing (acute, sub-acute, late and very late) Evidence (Definite and Probable)

    Timing (acute, sub-acute, late and very late), Evidence (Definite and Probable)

    Measured: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years 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 posted6 Sep 2018
  2. Study startJan 2019 (estimated)
  3. Primary completionJun 2020 (estimated)
  4. Study completionJun 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03660202
Sponsor's protocol ID
FUTURE-III
Acronym
FUTURE-III
Status last verified
Sep 2018
First submitted
4 Sep 2018
Last updated
12 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jiang J, Li C, Chen D, Song L, Cui Z, Li P, Gan L, Chen Y, Li H, Jia S, He S, Lu W, Gao R, Wang J; FUTURE III Investigators. Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomes. BMC Med. 2025 Jul 9;23(1):419. doi: 10.1186/s12916-025-04254-0.

    PubMed 40629329

Questions about this trial

What is this clinical trial studying?

A study testing Firesorb in people with Coronary Artery Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.

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

Who may be eligible to take part?

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 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Bo Xu, MBBS (010-88322562, bxu@citmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number and rate of Target Lesion Failure(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 NCT03660202, 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 12 Sep 2018.

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Trial for MicroPort's Firesorb BVS: FUTURE-III | AzTrials