Peripheral Arterial Occlusive Disease (PAOD)PERFECTIONNCT01601496
Evaluation of FUSION™ Vascular Graft for Above Knee Targets
A study testing FUSION Vascular Graft in people with Peripheral Arterial Occlusive Disease (PAOD), run by Maquet Cardiovascular at 10 sites in 2 countries.
Trial summary
The purpose of the post-market study was to evaluate the safety and performance of the FUSION Vascular Graft. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Arterial Occlusive Disease (PAOD)
- What is being tested?
- FUSION Vascular Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 26 Oct 2009to 24 Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany9 sites
Klinikum Darmstadt
Darmstadt, 64283
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590
Klinikum Karlsruhe
Karlsruhe, 76133
Marienhospital Kevelaer
Kevelaer, 47623
Klinikum Ludwigsburg
Ludwigsburg, 71640
Klinikum München-Pasing
München, 81241
Klinikum rechts der Isar
München, 81675
Mathias-Spital
Rheine, 48431
Katharinenhospital
Stuttgart, 70147
About this study
Official title: 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.
Read the 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.
- Being tested
- FUSION Vascular Graft
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FUSION Vascular GraftDevice
All subjects who received the FUSION Vascular Graft at the baseline implant procedure.
| Study group | Role | What they receive |
|---|---|---|
| FUSION Vascular Graft | Experimental | All subjects who received a FUSION Vascular Graft at the baseline implant procedure. Receives: Device: FUSION Vascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (4)
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.
Measured: 12 Months
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.
Measured: 30 days, 6 months, 12 months
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).
Measured: 30 days, 6 months, 12 months
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study start26 Oct 2009
- Primary completion24 Jul 2013
- Study completion24 Jul 2013
Why it stopped: Slow Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial Occlusive Disease (PAOD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients treated with the FUSION Vascular Graft
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maquet Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Eckstein, Principal investigator, Klinikum rechts der IsarAfshin Assadian, MD, Principal investigator, Wilhelminenspital Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601496
- Sponsor's protocol ID
- VR7000856
- Acronym
- PERFECTION
- Status last verified
- Oct 2020
- First submitted
- 23 Apr 2012
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25498193
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of PERipheral Bypass GraFting: ProspECTive Evaluation of FUSION™ Vascular Graft for Above Knee Targets(PERFECTION)
- ClinicalTrials.gov ID
- NCT01601496
- Acronym / sponsor ID
- PERFECTION / VR7000856
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Enrollment
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Maquet CardiovascularIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2009 (actual)
- Primary completion
- 24 Jul 2013 (actual)
- Study completion
- 24 Jul 2013 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients treated with the FUSION Vascular Graft
| Arm | Type | Receives |
|---|---|---|
| FUSION Vascular Graft | Experimental | Device: FUSION Vascular GraftAll subjects who received a FUSION Vascular Graft at the baseline implant procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FUSION Vascular GraftAll subjects who received the FUSION Vascular Graft at the baseline implant procedure. | Device | FUSION Vascular Graft |
Primary outcome
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.
4 secondary outcomes
Participants With Secondary Graft Patency at 12 Months
Time frame: 12 Months
Mean Ankle-brachial Index 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
Time frame: 30 days, 6 months, 12 months
Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25498193Assadian 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.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Occlusive Disease (PAOD)
Active, not recruiting
Resoloy Initial Safety Evaluation
CLTI Defined as Rutherford Category 4 or 5, PAOD (Peripheral Arterial Obstructive Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Eckstein principal investigator
Klinikum rechts der Isar
Afshin Assadian, MD principal investigator
Wilhelminenspital Vienna
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FUSION Vascular Graft in people with Peripheral Arterial Occlusive Disease (PAOD), run by Maquet Cardiovascular at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Primary Graft Patency at 12 Months (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01601496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.