A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II

NCT02890160 | Unknown DMC

• 1 other identifier: MicroPort_Firesorb_RCT
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

The FUTURE-II 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)

• In-segment Late Lumen Loss (LLL) (Queue 1)

  In-segment late lumen loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5mm proximal and 5mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

  1 year after index procedure

Secondary Outcomes (19)

• The percentage of intima coverage-strut (OCT subgroup)

  1 year after index procedure

• Vasomotion (Queue 2)

  2 year after index procedure

• 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,1 year,2 years,3 years,4 years and 5 years after index procedure

Study Arms (2)

Firesorb

EXPERIMENTAL

Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold （Firesorb）

Device: Firesorb

XIENCE

ACTIVE COMPARATOR

Implantation of the XIENCE Everolimus Eluting Coronary Stent System

Device: XIENCE

Interventions

Firesorb DEVICE

Sirolimus Target Eluting Bioresorbable Vascular Scaffold

Firesorb

XIENCE DEVICE

Everolimus Eluting Coronary Stent System

XIENCE

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.
• One or two de novo target lesions:
• If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
• If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
• 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 or quantitatively assessed % diameter stenosis (DS) of ≥ 50% and \< 100% with a thrombolysis in myocardial infarction (TIMI) flow of ≥1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g. fractional flow reserve, stress test), unstable angina or post-infarct angina. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.5 mm and ≤4.0 mm. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 25 mm.
• 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;
• Within six months for elective surgery requires stopping aspirin, Clopidogrel patients;

Sponsors & Collaborators

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

Study Sites (1)

Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (2)

• 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

• Song L, Xu B, Chen Y, Zhou Y, Jia S, Zhong Z, Su X, Ma Y, Zhang Q, Liu J, Wang Y, Guan C, Zheng M, Qiao S, Gao R; FUTURE-II Trial Investigators. Thinner Strut Sirolimus-Eluting BRS Versus EES in Patients With Coronary Artery Disease: FUTURE-II Trial. JACC Cardiovasc Interv. 2021 Jul 12;14(13):1450-1462. doi: 10.1016/j.jcin.2021.04.048. Epub 2021 May 18.

  PMID: 34238555 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Runlin Gao, MD

  Fu Wai Hospital & National Center for Cardiovascular Diseases in China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: August 24, 2017
• Primary Completion: October 31, 2020
• Study Completion: October 1, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

CN (1)