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A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II | Clinical Trials | Clareo Health

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

A Randomized Trial of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease: FUTURE-II

NCT02890160•Shanghai MicroPort Medical (Group) Co., Ltd.

View on ClinicalTrials.gov

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.

Detailed Description

This study is a prospective, multicenter, single-blind, randomized controlled 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. The Abbott's XIENCE Everolimus-eluting Coronary Stent System is selected as the control device. 430 subjects will be recruited. All subjects will be 1:1 randomly assigned to experimental group and control group. 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. All subjects will undergo angiographic follow-up at 1-year post-index procedure; of which 3-5 centers will be specified as a subgroup to complete OCT follow-up (n=80, 40 each in test and control group).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
•4. To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
•1. One or two de novo target lesions:
•1. 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.
•2. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
•3. 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.
•2. 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.
•3. Each target lesion may be covered with one stent.

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 , patients with planned intervention again within six months;
•3. Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction \<40% (ultrasound or left ventricular angiography);
•4. Preoperative renal function serum creatinine \>2.0mg/DL; receiving hemodialysis;
•5. 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;
•6. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
•7. The patient's life expectancy is less than 12 months;
•8. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
•9. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
•10. Heart transplantation patients;
+31 more criteria

Locations (1)

Fu Wai Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

August 24, 2017

Primary Completion Date

October 31, 2020

Completion Date

October 1, 2024

Last Updated

October 25, 2023

Enrollment

430

ESTIMATED participants

Conditions

Coronary Artery Disease

Interventions

Firesorb

DEVICE

XIENCE

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 25, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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