Coronary Artery DiseaseFUTURE-INCT02659254

A First-in-Man Study of the Firesorb BVS (FUTURE-I)

A study testing Sirolimus Target Eluting Bioresorbable Vascular Scaffold in people with Coronary Artery Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a small scale pilot trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) in Patients with Coronary Artery Disease for the first time. The goal is to access the preliminary safety and efficacy of Firesorb implantation in the human body, and to provide evidence for subsequent… 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?: Sirolimus Target Eluting Bioresorbable Vascular Scaffold
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteChina
Study dates: Jan 2016to Mar 2021
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

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;
Total number of target lesion is 1;
Target lesion length ≤ 25mm (Visual); target lesion diameter between 3.0mm to 3.5mm;
Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
Each target lesion may be covered by a single stent;
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.

Who cannot join

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 class III and above) ,left ventricular ejection fraction or <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;

Show all 17Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Fu Wai Hospital
Beijing, Beijing Municipality, 100037

Other trials in China

About this study

Official title: A First-in-Man Study of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease: FUTURE-I

Read the detailed description

This study is a prospective, single-center clinical trial. The investigator design to recruit 45 subjects. After implanting the Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) successfully, all the subjects will be randomly assigned to queue 1 (n=30) and queue 2 (n=15). The clinical follow-up will be performed in all subjects at 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after scaffold implantation. Angiographic,IVUS and OCT follow-up will be performed at 6 months and 2 years after scaffold implantation in queue 1; angiographic,IVUS and OCT follow-up will be performed at 1 year and 3 years after scaffold implantation in queue 2. The primary endpoint of the study is target lesion failure (TLF) at 30 days after scaffold implantation, the secondary endpoints are series of imaging outcomes, for evaluation of feasibility and preliminary safety and efficacy of the product.

Conditions: Coronary Artery Disease
Being tested: Sirolimus Target Eluting Bioresorbable Vascular Scaffold
Keywords: Drug-Eluting Stents,Absorbable Implants,Stents
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.

Sirolimus Target Eluting Bioresorbable Vascular ScaffoldDevice
Also called Firesorb
Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold

Study groups in NCT02659254
Study group	Role	What they receive
Firesorb Implantation	Experimental	Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold （Firesorb）in patients with coronary artery lesions. Receives: Device: Sirolimus Target Eluting Bioresorbable Vascular Scaffold

What is being measured

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

Device-oriented composite endpoints (Target Lesion Failure)
Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization.
Measured: 1 month after index procedure

Secondary outcomes (10)

Target Lesion Failure
Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization.
Measured: 6 months,1 year,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
Device Success
Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by visual.
Measured: From the start of index procedure to end of index procedure
Procedural Success
Achievement of final in-scaffold/stent residual stenosis of less than 30% by visual estimation with successful delivery and deployment of at least one assigned scaffold/stent 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
Scaffold Thrombosis/Stent Thrombosis (per ARC definition)
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
In-device, in-segment, proximal and distal minimum lumen diameter (MLD)
Angiographic endpoint.
Measured: 6 months,1 year,2 years and 3 years after index procedure
In-device, in-segment, proximal and distal % diameter stenosis (DS)
Angiographic endpoint.
Measured: 6 months,1 year,2 years and 3 years after index procedure
In-device, in-segment, proximal and distal angiographic binary restenosis (ABR)
Angiographic endpoint.
Measured: 6 months,1 year,2 years and 3 years after index procedure
In-device, in-segment,proximal and distal late lumen loss (LLL)
Angiographic endpoint.
Measured: 6 months,1 year,2 years and 3 years after index procedur
Vasomotion
The changes in average lumen diameter before and after intracoronary nitroglycerin.
Measured: 6 months,1 year,2 years and 3 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.

Jan 2016Mar 2021

First posted20 Jan 2016 (estimated)
Study startJan 2016
Primary completionMay 2016
Study completionMar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02659254
Sponsor's protocol ID: MicroPort_Firesorb_FIM
Acronym: FUTURE-I
Status last verified: Oct 2023
First submitted: 15 Jan 2016
Last updated: 25 Oct 2023
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A First-in-Man Study of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease: FUTURE-I
ClinicalTrials.gov ID: NCT02659254
Acronym / sponsor ID: FUTURE-I / MicroPort_Firesorb_FIM
Conditions: Coronary Artery Disease
Keywords: Drug-Eluting Stents,Absorbable Implants,Stents
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2016 (actual)
Primary completion: May 2016 (actual)
Study completion: Mar 2021 (actual)
First posted: 20 Jan 2016 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Firesorb Implantation	Experimental	Device: Sirolimus Target Eluting Bioresorbable Vascular ScaffoldImplantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold （Firesorb）in patients with coronary artery lesions.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;
Total number of target lesion is 1;
Target lesion length ≤ 25mm (Visual); target lesion diameter between 3.0mm to 3.5mm;
Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;

Key exclusion criteria (17 listed)

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 class III and above) ,left ventricular ejection fraction or <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;

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
Sirolimus Target Eluting Bioresorbable Vascular ScaffoldAlso: FiresorbImplantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold	Device	Firesorb Implantation

Primary outcome

Device-oriented composite endpoints (Target Lesion Failure)
Time frame: 1 month after index procedure
Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization.

10 secondary outcomes

Target Lesion Failure
Time frame: 6 months,1 year,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
Device Success
Time frame: From the start of index procedure to end of index procedure
Procedural Success
Time frame: At time of procedure up to 7 days in hospital
Scaffold Thrombosis/Stent Thrombosis (per ARC definition)
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
In-device, in-segment, proximal and distal minimum lumen diameter (MLD)
Time frame: 6 months,1 year,2 years and 3 years after index procedure
In-device, in-segment, proximal and distal % diameter stenosis (DS)
Time frame: 6 months,1 year,2 years and 3 years after index procedure
In-device, in-segment, proximal and distal angiographic binary restenosis (ABR)
Time frame: 6 months,1 year,2 years and 3 years after index procedure
In-device, in-segment,proximal and distal late lumen loss (LLL)
Time frame: 6 months,1 year,2 years and 3 years after index procedur
Vasomotion
Time frame: 6 months,1 year,2 years and 3 years after index procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
Individual participant dataSharing planned: Undecided

Related trials for Coronary Artery Disease

RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
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ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
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Recruiting
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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.

Runlin Gao, MD principal investigator

Fu Wai Hospital & National Center for Cardiovascular Diseases in China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sirolimus Target Eluting Bioresorbable Vascular Scaffold 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?

The sponsor lists 8 inclusion and 17 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: finished, as of the sponsor's last update on 25 Oct 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Device-oriented composite endpoints (Target Lesion Failure) (time frame: 1 month 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 NCT02659254.

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 25 Oct 2023.