Trial for MicroPort's Firesorb BVS: FUTURE-III

NCT03660202 | Unknown DMC

• 1 other identifier: FUTURE-III
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Bioresorbable Vascular Scaffold

Outcome Measures

Primary Outcomes (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.

  1 year after index procedure

Secondary Outcomes (10)

• The number and rate of Acute Success-Device Success

  From the start of index procedure to end of index procedure

• Acute Success-Procedural Success

  At time of procedure up to 7 days in hospital

• Device-oriented composite endpoints (Target Lesion Failure)

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

• Patient-oriented clinical composite endpoint (PoCE)

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

• Death (Cardiac, Vascular, Non-cardiovascular)

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

Study Arms (1)

Single Arm

EXPERIMENTAL

Single Arm Safety and Effectiveness Confirmatory Study of Firesorb BVS

Device: Firesorb

Interventions

Firesorb DEVICE

Implantation of Sirolimus Target Eluting Bioresorbable Vascular Scaffold （Firesorb）

Single Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• b. 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.
• c. 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.: lead

Study Sites (1)

Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (1)

• 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.

  PMID: 40629329 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Bo Xu, MBBS

CONTACT

010-88322562; bxu@citmd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: January 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2024
• Last Updated: September 12, 2018

Record last verified: 2018-09

Locations

CN (1)