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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659254
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai MicroPort Medical (Group) Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Sirolimus Target Eluting Bioresorbable Vascular Scaffold Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: Firesorb Implantation
Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb)in patients with coronary artery lesions.
Device: Sirolimus Target Eluting Bioresorbable Vascular Scaffold
Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold
Other Name: Firesorb




Primary Outcome Measures :
  1. Device-oriented composite endpoints (Target Lesion Failure) [ Time Frame: 1 month after index procedure ]
    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 :
  1. Target Lesion Failure [ Time Frame: 6 months,1 year,2 years,3 years,4 years and 5 years after index procedure ]
    Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization.

  2. Patient-oriented clinical composite endpoint (PoCE) [ Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure ]
    Patient-oriented clinical composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization.

  3. Device Success [ Time Frame: From the start of index procedure to end of index procedure ]
    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.

  4. Procedural Success [ Time Frame: At time of procedure up to 7 days in hospital ]
    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.

  5. Scaffold Thrombosis/Stent Thrombosis (per ARC definition) [ Time Frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure ]
    Timing (acute, sub-acute, late and very late) Evidence (definite and probable)

  6. In-device, in-segment, proximal and distal minimum lumen diameter (MLD) [ Time Frame: 6 months,1 year,2 years and 3 years after index procedure ]
    Angiographic endpoint.

  7. In-device, in-segment, proximal and distal % diameter stenosis (DS) [ Time Frame: 6 months,1 year,2 years and 3 years after index procedure ]
    Angiographic endpoint.

  8. In-device, in-segment, proximal and distal angiographic binary restenosis (ABR) [ Time Frame: 6 months,1 year,2 years and 3 years after index procedure ]
    Angiographic endpoint.

  9. In-device, in-segment,proximal and distal late lumen loss (LLL) [ Time Frame: 6 months,1 year,2 years and 3 years after index procedur ]
    Angiographic endpoint.

  10. Vasomotion [ Time Frame: 6 months,1 year,2 years and 3 years after index procedure ]
    The changes in average lumen diameter before and after intracoronary nitroglycerin.


Other Outcome Measures:
  1. Descriptive analysis of morphometric, lesion composition and scaffold strut data obtained with OCT [ Time Frame: Immediate,6 months,1 year,2 years and 3 years after index procedure ]
    OCT endpoint.

  2. Descriptive analysis of vascular and scaffold morphology obtained with IVUS [ Time Frame: 6 months,1 year,2 years and 3 years after index procedure ]
    IVUS endpoint.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Total number of target lesion is 1;
  4. Target lesion length ≤ 25mm (Visual); target lesion diameter between 3.0mm to 3.5mm;
  5. Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
  6. Each target lesion may be covered by a single stent;
  7. Patients with indications for coronary artery bypass graft surgery;
  8. To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

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 class III and above) ,left ventricular ejection fraction or <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;
  11. The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
  12. Cancer need chemotherapy;
  13. Immunosuppression and autoimmune diseases, planned or undergoing immunosuppressive therapy;
  14. Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
  15. Within six months for elective surgery requires stopping aspirin, Clopidogrel patients;
  16. 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);
  17. Peripheral vascular disease, 6F catheter is not available.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659254


Locations
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China, Beijing
Fu Wai Hospital
Peking, Beijing, China, 100037
Sponsors and Collaborators
Shanghai MicroPort Medical (Group) Co., Ltd.
Investigators
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Principal Investigator: Runlin Gao, MD Fu Wai Hospital & National Center for Cardiovascular Diseases in China
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Responsible Party: Shanghai MicroPort Medical (Group) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02659254    
Other Study ID Numbers: MicroPort_Firesorb_FIM
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shanghai MicroPort Medical (Group) Co., Ltd.:
Drug-Eluting Stents,Absorbable Implants,Stents
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs