Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass. (FINEST)

May 12, 2020 updated by: Maquet Cardiovascular

Comparison of Safety and Primary Patency Between FUSION Vascular Graft With Bioline and EXXCEL Soft ePTFE (FINEST)

To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a prospective, randomized, single-blind, two-arm, parallel group, multi-center study to evaluate the safety and efficacy of FUSION™ Vascular Graft with Bioline (heparin) coating, compared with EXXCEL Soft ePTFE in a peripheral bypass setting, to support a claim of substantial equivalence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 625 00
        • Fakulti nemocnice Brno
      • Brno, Czechia, 656 91
        • Fakultni Nemocnice u sv Anny v Brno
      • Plzen, Czechia, 304 60
        • University Hospital Plzen
      • Prague, Czechia, 150 30
        • Nemocnice na Homolce
      • Prague, Czechia, 128 08
        • Vseobecna Fakultni Nemocnice (VFN) Praha
      • Prague, Czechia, 140 21
        • IKEM Praha
  • Germany
      • Karlsruhe, Germany, 76133
        • Klinikum Karlsruhe
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama-Birmingham Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Central Arkansas Veterans Health System
    • California
      • Palo Alto, California, United States, 94304
        • VA Palo Alto HCS
    • Florida
      • Tampa, Florida, United States, 33606
        • University of South Florida - Tampa General
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth- Hitchcock Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Bronx, New York, United States, 10461
        • Montefiore Weiler Hospital
      • New York, New York, United States, 10016
        • NYU School of Medicine
      • New York, New York, United States, 10032
        • NY Presbyterian Hospital - Columbia Univ Medical Center
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center
      • Houston, Texas, United States, 77030
        • Methodist Hospital
      • Temple, Texas, United States, 76504
        • Central Texas Veterans Health System
      • Temple, Texas, United States, 76508
        • Scott & White
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Norfolk Sentara - Norfolk General Hospital
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient required either above-knee or below-knee femoral popliteal bypass;
  • Patient had Category 1, 2, 3 4 or 5 chronic limb ischemia as defined by the Rutherford Categories - chronic limb ischemia severity classification scale.
  • Patient was at least 21 years of age;
  • Patient had postoperative life expectancy of >18 months;
  • Patient was willing and able to have follow-up visits and examinations;
  • Patient would not participate in other clinical trials that would conflict with this protocol
  • Patient was willing and able to provide written, informed consent.

Exclusion Criteria:

  • Patient had a previous history of bypass in the diseased extremity (below the iliacs arteries);
  • Patient had percutaneous transluminal angioplasty or stenting of the target femoral or popliteal artery at the anticipated site of the proximal or distal anastomosis within the previous 30 days;
  • Patient had active infection in the region of graft placement;
  • Patient had an acute arterial occlusion requiring an emergent intervention;
  • Patient needed a cardiac surgical procedure or a different vascular surgical procedure within 30 days of planned lower extremity revascularization. Planned endovascular procedures to address proximal stenotic lesions at the time of the index femoropopliteal bypass did not exclude a patient from the study;
  • Patient required sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
  • Patient had known hypersensitivity or contraindication to aspirin;
  • Patient had known coagulation disorders including hypercoagulability;
  • Patient had previous instance of heparin-induced thrombocytopenia type 2 or has known hypersensitivity to heparin; Patient was currently treated with Coumadin (warfarin) that had not been stopped within 72 hours of the planned procedure
  • Patient had severe chronic renal insufficiency (plasma/serum creatinine > 2.5 mg/dl), is undergoing hemodialysis.
  • Patient had prior renal transplant;
  • Patient had a stroke or myocardial infarction within 6 weeks of the procedure or had evidence of prior massive stroke (Modified Rankin Scale 3 or above);
  • Patient had a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris;
  • Patient had documented acute or suspected systemic infection;
  • Patient was a woman of reproductive potential.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: EXXCEL Soft
A vascular graft comprised of extruded, expanded polytetrafluroethylene (ePTFE), indicated for use as a vascular prosthesis for replacement or bypass of diseased peripheral arteries (510(k) K962433).
Device: vascular grafts
All devices will be used to treat patients with peripheral arterial occlusive disease
EXPERIMENTAL: FUSION Bioline
A synthetic vascular graft constructed of two layers. The inner layer is comprised of extruded, ePTFE. The outer layer is comprised of knit polyester textile. These two layers are fused together with a proprietary polycarbonate-urethane adhesive. The vascular graft also has a heparin coating on the graft's luminal surface. The Bioline coating is a bioactive surface coating consisting of a covalent Heparin Sodium coupled to immobilized recombinant human albumin.
Device: vascular grafts
All devices will be used to treat patients with peripheral arterial occlusive disease

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Primary Patency
Time Frame: 6 months
A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency. Assessed by duplex ultrasound imaging and ankle brachial index (ABI).
6 months
The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD)
Time Frame: 6 months

The composite endpoint included any of the following:

  • Major amputation - amputation that resulted in limb shortening (e.g., proximal to, but not including transmetatarsal amputations);
  • Major graft reintervention - placement of a new bypass graft at the same anatomic site, a jump/interposition graft, graft thrombectomy, graft excision, or graft thrombolysis;
  • Procedure-related death - any death within 30 days of the index procedure or within 30 days of any remedial procedure performed at the same anatomic site or as a result of the index procedure.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Primary Assisted Patency
Time Frame: 6 months
Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft.
6 months
Number of Participants With Secondary Patency
Time Frame: 6 months
Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion.
6 months
Time to Hemostasis of Suture Hole Bleeding (Min)
Time Frame: Post-procedure
Time from the release of clamps until hemostasis, where hemostasis is defined as the absence of detectable bleeding from any of the suture holes.
Post-procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Primary Patency
Time Frame: 30 days
A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency.
30 days
Number of Participants With Primary Patency
Time Frame: 12 months
A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency.
12 months
Number of Participants With Primary Assisted Patency
Time Frame: 30 days
Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft.
30 days
Number of Participants With Primary Assisted Patency
Time Frame: 12 months
Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft.
12 months
Number of Participants With Secondary Patency
Time Frame: 30 days
Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion.
30 days
Number of Participants With Secondary Patency
Time Frame: 12 months
Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maquet Cardiovascular

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alan Lumsden, MD, The Methodist Hospital Research Institute
  • Principal Investigator: Nicholas J. Morrissey, MD, NY Presbyterian-Columbia U Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 4, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCV00001506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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