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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Sirolimus Target Eluting Bioresorbable Vascular Scaffold

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug-Eluting Stents,Absorbable Implants,Stents

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.

Sites / Locations

Fu Wai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Firesorb Implantation

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Patient-oriented clinical composite endpoint (PoCE)

Patient-oriented clinical composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization.

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.

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.

Scaffold Thrombosis/Stent Thrombosis (per ARC definition)

Timing (acute, sub-acute, late and very late) Evidence (definite and probable)

In-device, in-segment, proximal and distal minimum lumen diameter (MLD)

Angiographic endpoint.

In-device, in-segment, proximal and distal % diameter stenosis (DS)

Angiographic endpoint.

In-device, in-segment, proximal and distal angiographic binary restenosis (ABR)

Angiographic endpoint.

In-device, in-segment,proximal and distal late lumen loss (LLL)

Angiographic endpoint.

Vasomotion

The changes in average lumen diameter before and after intracoronary nitroglycerin.

Full Information

NCT ID

NCT02659254

First Posted

January 15, 2016

Last Updated

October 23, 2023

Sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02659254

Brief Title

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

Acronym

FUTURE-I

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Drug-Eluting Stents,Absorbable Implants,Stents

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Firesorb Implantation

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Sirolimus Target Eluting Bioresorbable Vascular Scaffold

Other Intervention Name(s)

Firesorb

Intervention Description

Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold

Primary Outcome Measure Information:

Title

Device-oriented composite endpoints (Target Lesion Failure)

Description

Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization.

Time Frame

1 month after index procedure

Secondary Outcome Measure Information:

Title

Target Lesion Failure

Description

Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization.

Time Frame

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

Title

Patient-oriented clinical composite endpoint (PoCE)

Description

Patient-oriented clinical composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization.

Time Frame

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

Title

Device Success

Description

Time Frame

From the start of index procedure to end of index procedure

Title

Procedural Success

Description

Time Frame

At time of procedure up to 7 days in hospital

Title

Scaffold Thrombosis/Stent Thrombosis (per ARC definition)

Description

Timing (acute, sub-acute, late and very late) Evidence (definite and probable)

Time Frame

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

Title

In-device, in-segment, proximal and distal minimum lumen diameter (MLD)

Description

Angiographic endpoint.

Time Frame

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

Title

In-device, in-segment, proximal and distal % diameter stenosis (DS)

Description

Angiographic endpoint.

Time Frame

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

Title

In-device, in-segment, proximal and distal angiographic binary restenosis (ABR)

Description

Angiographic endpoint.

Time Frame

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

Title

In-device, in-segment,proximal and distal late lumen loss (LLL)

Description

Angiographic endpoint.

Time Frame

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

Title

Vasomotion

Description

The changes in average lumen diameter before and after intracoronary nitroglycerin.

Time Frame

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

Other Pre-specified Outcome Measures:

Title

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

Description

OCT endpoint.

Time Frame

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

Title

Descriptive analysis of vascular and scaffold morphology obtained with IVUS

Description

IVUS endpoint.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Runlin Gao, MD

Organizational Affiliation

Fu Wai Hospital & National Center for Cardiovascular Diseases in China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fu Wai Hospital

City

Peking

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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