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.
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:
- 18-75 years of age, males or non-pregnant females;
- With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
- 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:
- General Specification Subgroup:
- 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.
- 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.
- Each target lesion may be covered with one stent.
- Long Lesion Subgroup:
- One de novo target lesion.
- 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.
- Each target lesion may be covered with one stent.
General Exclusion Criteria:
- Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
- Implantation of stent in target vessel within 1 year;
- Patients with planned intervention again within six months;
- Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction <40% (ultrasound or left ventricular angiography);
- Preoperative renal function serum creatinine >2.0mg/DL; receiving hemodialysis;
- 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;
- Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
- The patient's life expectancy is less than 12 months;
- Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
- Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
- Heart transplantation patients;
- The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
- Cancer need chemotherapy;
- Immunosuppression and autoimmune diseases, planned or undergoing immunosuppressive therapy;
- Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
- Within six months for elective surgery requires stopping aspirin, Clopidogrel patients;
- 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);
- Peripheral vascular disease, 6F catheter is not available.
Angiographic Exclusion Criteria:
- Left main coronary artery disease;
- Severe triple vessel lesion and required revascularization.
The following exclusion criteria apply to the target lesion(s) or target vessel(s):
- Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
- Lesion located within 3 mm of the origin of the Left Anterior Descending Artery (LAD) or left circumflex artery (LCX).
- 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 :
- Extreme angulation (≥ 90°) proximal to or within the target lesion.
- Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
- 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.
- 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.
- Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
- Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
- Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is strongly recommended.
- TIMI Grade-3 flow (per visual estimation).
- No angiographic complications (e.g. distal embolization, side branch closure).
- No dissections National Heart Lung and Blood Institute (NHLBI) grade D-F.
- No chest pain lasting > 5 minutes.
- No ST depression or elevation lasting > 5 minutes.
Trial locations and contacts
1 site in 1 country.
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.
- Conditions
- Coronary Artery Disease
- 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 group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Single 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.
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)
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
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
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
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
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
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
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
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
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
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.
- First posted6 Sep 2018
- Study startJan 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03660202
- Acronym / sponsor ID
- FUTURE-III / FUTURE-III
- Conditions
- Coronary Artery Disease
- Keywords
- Bioresorbable Vascular Scaffold
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: FiresorbSingle Arm Safety and Effectiveness Confirmatory Study of Firesorb BVS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiresorbImplantation of Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) | Device | Single Arm |
Primary outcome
The number and rate of Target Lesion Failure(TLF)
Time frame: 1 year after index procedure
Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and ischemia-driven target lesion revascularization.
10 secondary outcomes
The number and rate of Acute Success-Device Success
Time frame: From the start of index procedure to end of index procedure
Acute Success-Procedural Success
Time frame: At time of procedure up to 7 days in hospital
Device-oriented composite endpoints (Target Lesion Failure)
Time frame: 1 month,6 months,2 years,3 years,4 years and 5 years after index procedure
Patient-oriented clinical composite endpoint (PoCE)
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
The number and rate of Myocardial Infarction (MI)
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
The number and rate of Target Vessel Revascularization (TVR)
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
The number and rate of Target Lesion Revascularization (TLR)
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
The number and rate of Any Revascularization
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
The number and rate of Scaffold Thrombosis (per ARC definition)
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Derived from this study: PubMed 40629329Jiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.