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

NCT02659254 | Completed DMC

• 1 other identifier: MicroPort_Firesorb_FIM
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 large-scale, multi-center, randomized controlled clinical trials. Then provide the basis for the formal application of the product in China.

Conditions

Coronary Artery Disease

Keywords

Drug-Eluting Stents,Absorbable Implants,Stents

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month after index procedure

Secondary Outcomes (10)

• Target Lesion Failure

  6 months,1 year,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

• Device Success

  From the start of index procedure to end of index procedure

• Procedural Success

  At time of procedure up to 7 days in hospital

• Scaffold Thrombosis/Stent Thrombosis (per ARC definition)

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

Other Outcomes (2)

• Descriptive analysis of morphometric, lesion composition and scaffold strut data obtained with OCT

  Immediate,6 months,1 year,2 years and 3 years after index procedure

• Descriptive analysis of vascular and scaffold morphology obtained with IVUS

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

Study Arms (1)

Firesorb Implantation

EXPERIMENTAL

Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold （Firesorb）in patients with coronary artery lesions.

Device: Sirolimus Target Eluting Bioresorbable Vascular Scaffold

Interventions

Sirolimus Target Eluting Bioresorbable Vascular Scaffold DEVICE

Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold

Also known as: Firesorb

Firesorb Implantation

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;
• 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.

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 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;
• 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

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 20, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: March 1, 2021
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

CN (1)