Evaluation of FUSION™ Vascular Graft for Above Knee Targets (PERFECTION)

October 12, 2020 updated by: Maquet Cardiovascular

Study of PERipheral Bypass GraFting: ProspECTive Evaluation of FUSION™ Vascular Graft for Above Knee Targets(PERFECTION)

The purpose of the post-market study was to evaluate the safety and performance of the FUSION Vascular Graft.

Study Overview

Status

Status

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

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

This study was a prospective, single-arm, multicenter study conducted in Germany and Austria to evaluate the FUSION Vascular Graft in patients with peripheral arterial occlusive disease undergoing above-the-knee bypass. Follow-up visits were performed at 30 days, 6 months, 12 months and included patency and post operative complications not associated with bypass patency.

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.
117

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

  • Austria
      • Vienna, Austria, A-1160
        • Wilhelminenspital Vienna
  • Germany
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt
      • Frankfurt am Main, Germany, 60590
        • Universitätsklinikum Frankfurt
      • Karlsruhe, Germany, 76133
        • Klinikum Karlsruhe
      • Kevelaer, Germany, 47623
        • Marienhospital Kevelaer
      • Ludwigsburg, Germany, 71640
        • Klinikum Ludwigsburg
      • München, Germany, 81675
        • Klinikum rechts der Isar
      • München, Germany, 81241
        • Klinikum München-Pasing
      • Rheine, Germany, 48431
        • Mathias-Spital
      • Stuttgart, Germany, 70147
        • Katharinenhospital

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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No known malignant disease
  • Patient was willing and able to have follow-up visits and examinations
  • Peripheral arterial occlusive disease (PAOD) requiring treatment of the femoral artery; Fontaine stage IIb, III and IV with dry peripheral gangrene, and suitable for surgery
  • Patient was not participating in other clinical trials that would conflict with this protocol
  • Patient agreed to the study provisions and provided written informed consent

Exclusion Criteria:

  • Urgent or emergent surgery of any kind
  • Documented acute or suspected systemic infection
  • Life expectancy of less than one year
  • Patients who had a minor or major stroke within 6 weeks of the procedure or who had evidence of prior massive stroke
  • Patients who had experienced a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris
  • Severe chronic renal insufficiency or undergoing hemodialysis
  • Patients treated with coumadin (warfarin) that had not been stopped within 72 before enrollment
  • Medical conditions requiring oral anticoagulation
  • Antiplatelet therapy with clopidogrel or dual antiplatelet as well as any other antithrombotic medication within 7 days prior to scheduled bypass surgery except unfractionated heparin or aspirin
  • International normalized ratio (INR) > 2.0
  • Known hypersensitivity to heparin
  • Patient not tolerating aspirin
  • Previous history of bypass surgery in the target limb
  • Patient with category 6 ischemia (tissue loss)
  • Acute limb ischemia of any grade (0-3)
  • Patient with no outflow beyond the popliteal artery
  • Pregnant or may become pregnant during the course of the study
  • Uncontrolled arterial hypertension (BP > 200 mmHg) at 2 successive readings
  • Anaemia (hemoglobin < 8 g/ml)
  • Thrombocytopenia < 50 g/L
  • Active bleeding according to clinical judgment
  • Infected wet gangrene of any size and location at the target limb
  • Compromised arterial flow
  • Patient unwilling or unable to comply with follow-up requirements

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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.
EXPERIMENTAL: FUSION Vascular Graft
All subjects who received a FUSION Vascular Graft at the baseline implant procedure.
Device: FUSION Vascular Graft
All subjects who received the FUSION Vascular Graft at the baseline implant procedure.

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
Participants With Primary Graft Patency at 12 Months
Time Frame: 12 Months
Subjects were assessed to have had primary graft patency at 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 interventions. Patency was assessed by duplex ultrasound imaging.
12 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
Participants With Secondary Graft Patency at 12 Months
Time Frame: 12 Months
Subjects were assessed to have had secondary graft patency at 12 months. Secondary graft patency was defined as a graft patency established by another intervention to remediate occlusion within 12 months after surgery.
12 Months
Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months
Time Frame: 30 days, 6 months, 12 months
Ankle-brachial index at 30 days, 6 months, and 12 months. The ankle-brachial index is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm.
30 days, 6 months, 12 months
Rutherford Category at 30 Days, 6 Months and 12 Months
Time Frame: 30 days, 6 months, 12 months
Rutherford category at 30 days, 6 months and 12 months. Rutherford classification is a staging system to describe lower extremity ischemia, and is assigned by the Investigator. Higher grades represent more severe disease, ranging from asymptomatic (category 0) to major tissue loss (category 6).
30 days, 6 months, 12 months
Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death
Time Frame: 12 Months
Major Adverse Limb Events (MALE) were defined as major amputation (any amputation that resulted in limb shortening) or major graft reintervention (including placement of a new bypass graft at the same anatomic site, a jump/interposition graft, graft thrombectomy, graft excision (explant), or graft thrombolysis). Periprocedural Death (POD) was defined as death within 30 days of the index procedure or within 30 days of any remedial procedure performed at the same anatomical site or as a result of the initial procedure.
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: Prof. Eckstein, Klinikum rechts der Isar
  • Principal Investigator: Afshin Assadian, MD, Wilhelminenspital Vienna

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.
October 26, 2009

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.
July 24, 2013

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.
July 24, 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 23, 2012

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.
May 16, 2012

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.
May 18, 2012

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.
October 14, 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.
October 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.
October 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.
  • VR7000856

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

product manufactured in and exported from the U.S.

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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