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

Primary Purpose

Peripheral Arterial Occlusive Disease (PAOD)

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
FUSION Vascular Graft
Sponsored by
Maquet Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Occlusive Disease (PAOD)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wilhelminenspital Vienna
  • Klinikum Darmstadt
  • Universitätsklinikum Frankfurt
  • Klinikum Karlsruhe
  • Marienhospital Kevelaer
  • Klinikum Ludwigsburg
  • Klinikum München-Pasing
  • Klinikum rechts der Isar
  • Mathias-Spital
  • Katharinenhospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FUSION Vascular Graft

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Participants With Secondary Graft Patency at 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.
Mean Ankle-brachial Index at 30 Days, 6 Months and 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.
Rutherford Category at 30 Days, 6 Months and 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).
Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death
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.

Full Information

First Posted
April 23, 2012
Last Updated
October 12, 2020
Sponsor
Maquet Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT01601496
Brief Title
Evaluation of FUSION™ Vascular Graft for Above Knee Targets
Acronym
PERFECTION
Official Title
Study of PERipheral Bypass GraFting: ProspECTive Evaluation of FUSION™ Vascular Graft for Above Knee Targets(PERFECTION)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow Enrollment
Study Start Date
October 26, 2009 (Actual)
Primary Completion Date
July 24, 2013 (Actual)
Study Completion Date
July 24, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maquet Cardiovascular

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease (PAOD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients treated with the FUSION Vascular Graft
Masking
None (Open Label)
Allocation
N/A
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FUSION Vascular Graft
Arm Type
Experimental
Arm Description
All subjects who received a FUSION Vascular Graft at the baseline implant procedure.
Intervention Type
Device
Intervention Name(s)
FUSION Vascular Graft
Intervention Description
All subjects who received the FUSION Vascular Graft at the baseline implant procedure.
Primary Outcome Measure Information:
Title
Participants With Primary Graft Patency at 12 Months
Description
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.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Participants With Secondary Graft Patency at 12 Months
Description
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.
Time Frame
12 Months
Title
Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months
Description
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.
Time Frame
30 days, 6 months, 12 months
Title
Rutherford Category at 30 Days, 6 Months and 12 Months
Description
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).
Time Frame
30 days, 6 months, 12 months
Title
Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death
Description
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.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Eckstein
Organizational Affiliation
Klinikum rechts der Isar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Afshin Assadian, MD
Organizational Affiliation
Wilhelminenspital Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilhelminenspital Vienna
City
Vienna
ZIP/Postal Code
A-1160
Country
Austria
Facility Name
Klinikum Darmstadt
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Klinikum Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Marienhospital Kevelaer
City
Kevelaer
ZIP/Postal Code
47623
Country
Germany
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
Facility Name
Klinikum München-Pasing
City
München
ZIP/Postal Code
81241
Country
Germany
Facility Name
Klinikum rechts der Isar
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Mathias-Spital
City
Rheine
ZIP/Postal Code
48431
Country
Germany
Facility Name
Katharinenhospital
City
Stuttgart
ZIP/Postal Code
70147
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25498193
Citation
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.
Results Reference
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Evaluation of FUSION™ Vascular Graft for Above Knee Targets

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