Evaluation of FUSION™ Vascular Graft for Above Knee Targets

NCT01601496 | Terminated Results FDA Device

• 1 other identifier: VR7000856
• Study Type: interventional
• Target: 117
• Locations: 2 countries
• Sites: 10

Brief Summary

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

Conditions

Peripheral Arterial Occlusive Disease (PAOD)

Outcome Measures

Primary Outcomes (1)

• Participants With Primary Graft Patency at 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 Outcomes (4)

• Participants With Secondary Graft Patency at 12 Months

  12 Months

• Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months

  30 days, 6 months, 12 months

• Rutherford Category at 30 Days, 6 Months and 12 Months

  30 days, 6 months, 12 months

• Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death

  12 Months

Study Arms (1)

FUSION Vascular Graft

EXPERIMENTAL

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

Device: FUSION Vascular Graft

Interventions

FUSION Vascular Graft DEVICE

All subjects who received the FUSION Vascular Graft at the baseline implant procedure.

FUSION Vascular Graft

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maquet Cardiovascular: lead

Study Sites (10)

Wilhelminenspital Vienna

Vienna, A-1160, Austria

Location

Klinikum Darmstadt

Darmstadt, 64283, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Marienhospital Kevelaer

Kevelaer, 47623, Germany

Location

Klinikum Ludwigsburg

Ludwigsburg, 71640, Germany

Location

Klinikum München-Pasing

München, 81241, Germany

Location

Klinikum rechts der Isar

München, 81675, Germany

Location

Mathias-Spital

Rheine, 48431, Germany

Location

Katharinenhospital

Stuttgart, 70147, Germany

Location

Related Publications (1)

• Assadian A, Eckstein HH; Peripheral Bypass Grafting: Prospective Evaluation of FUSION Vascular Graft for Above Knee Targets (PERFECTION) Study Group. Outcome of the FUSION vascular graft for above-knee femoropopliteal bypass. J Vasc Surg. 2015 Mar;61(3):713-9.e1. doi: 10.1016/j.jvs.2014.10.005. Epub 2014 Dec 10.

  PMID: 25498193 RESULT

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Results Point of Contact

• Title: Elizabeth Bulger
• Organization: Getinge Group

Elizabeth.Bulger@getinge.com

603 880 1433 ext 5368

Study Officials

• Prof. Eckstein

  Klinikum rechts der Isar

  PRINCIPAL INVESTIGATOR

• Afshin Assadian, MD

  Wilhelminenspital Vienna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients treated with the FUSION Vascular Graft

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: May 18, 2012
• Study Start: October 26, 2009
• Primary Completion: July 24, 2013
• Study Completion: July 24, 2013
• Last Updated: October 14, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (9); AU (1)