Evaluation of FUSION™ Vascular Graft for Above Knee Targets (PERFECTION)
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|ClinicalTrials.gov Identifier: NCT01601496|
Recruitment Status : Terminated (Slow Enrollment)
First Posted : May 18, 2012
Results First Posted : October 14, 2020
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Occlusive Disease (PAOD)||Device: FUSION Vascular Graft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||117 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients treated with the FUSION Vascular Graft|
|Masking:||None (Open Label)|
|Official Title:||Study of PERipheral Bypass GraFting: ProspECTive Evaluation of FUSION™ Vascular Graft for Above Knee Targets(PERFECTION)|
|Actual Study Start Date :||October 26, 2009|
|Actual Primary Completion Date :||July 24, 2013|
|Actual Study Completion Date :||July 24, 2013|
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.
- 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.
- 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.
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601496
|Vienna, Austria, A-1160|
|Darmstadt, Germany, 64283|
|Frankfurt am Main, Germany, 60590|
|Karlsruhe, Germany, 76133|
|Kevelaer, Germany, 47623|
|Ludwigsburg, Germany, 71640|
|München, Germany, 81241|
|Klinikum rechts der Isar|
|München, Germany, 81675|
|Rheine, Germany, 48431|
|Stuttgart, Germany, 70147|
|Principal Investigator:||Prof. Eckstein||Klinikum rechts der Isar|
|Principal Investigator:||Afshin Assadian, MD||Wilhelminenspital Vienna|