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Slow Enrollment
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The purpose of the post-market study was to evaluate the safety and performance of the FUSION Vascular Graft.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FUSION Vascular Graft | Experimental | All subjects who received a FUSION Vascular Graft at the baseline implant procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FUSION Vascular Graft | Device | All subjects who received the FUSION Vascular Graft at the baseline implant procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
| Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Eckstein | Klinikum rechts der Isar | Principal Investigator |
| Afshin Assadian, MD | Wilhelminenspital Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilhelminenspital Vienna | Vienna | A-1160 | Austria | |||
| Klinikum Darmstadt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25498193 | Result | 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. |
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Patients were enrolled if they had peripheral artery occlusive disease (PAOD), signed informed consent forms, received subject numbers, and were screened for inclusion in the study. One subject failed to meet all eligibility criteria, prior to implantation of a FUSION vascular graft, and was not included in the efficacy or safety analyses.
Subjects were referred to and treated at 10 vascular surgery centers in Germany and Austria. Enrolled subjects received a FUSION Vascular Graft between October 2009 and May 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | FUSION Vascular Graft | All subjects who received a FUSION Vascular Graft at the baseline implant procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients with peripheral vascular disease who underwent femoral-to-above-knee popliteal bypass with a FUSION Vascular Graft.
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| ID | Title | Description |
|---|---|---|
| BG000 | FUSION Vascular Graft | All subjects who received a FUSION Vascular Graft at the baseline implant procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis limited to participants who were known primary patency failures (i.e. interventions were documented) or had a patency assessment at 12 months. | Posted | Count of Participants | Participants | 12 Months |
|
Through 12 months follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FUSION Vascular Graft | All subjects who receive a FUSION Vascular Graft at the baseline implant procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Bulger | Getinge Group | 603 880 1433 ext 5368 | Elizabeth.Bulger@getinge.com |
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| ID | Term |
|---|---|
| C564658 | Peripheral Arterial Occlusive Disease 1 |
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Patients treated with the FUSION Vascular Graft
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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 | 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 | 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 |
| Darmstadt |
| 64283 |
| Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | 60590 | Germany |
| Klinikum Karlsruhe | Karlsruhe | 76133 | Germany |
| Marienhospital Kevelaer | Kevelaer | 47623 | Germany |
| Klinikum Ludwigsburg | Ludwigsburg | 71640 | Germany |
| Klinikum München-Pasing | München | 81241 | Germany |
| Klinikum rechts der Isar | München | 81675 | Germany |
| Mathias-Spital | Rheine | 48431 | Germany |
| Katharinenhospital | Stuttgart | 70147 | Germany |
| Death |
|
| Other: patient refusal to continue |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Ankle-brachial index | The Ankle-brachial index is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm. | Patients with available measurement data for Ankle-brachial index. | Mean | Standard Deviation | ratio |
|
| Rutherford Category, No (%) | Pre-Intervention Rutherford Classification Category, as assigned by Investigator. Higher grades represent more severe disease, ranging from asymptomatic (category 0) to major tissue loss (category 6). | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Analysis limited to participants who had a patency assessment at 12 months or had been a secondary graft patency failure at a prior visit without restoration of flow. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | 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. | Patients with available ankle-brachial index measurements at the individual time point. Note that the number of patients with an ankle-brachial index measurement varies by time point. | Posted | Mean | Standard Deviation | ratio | 30 days, 6 months, 12 months |
|
|
|
| Secondary | 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). | Patients with available Rutherford classification at the individual time point. Note that the number of patients with an assigned Rutherford classification varies by time point. | Posted | Count of Participants | Participants | 30 days, 6 months, 12 months |
|
|
|
| Secondary | 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. | All subjects who received a FUSION Vascular Graft at the baseline implant procedure. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| 4 |
| 117 |
| 48 |
| 117 |
| 0 |
| 117 |
| Gallstone ileus | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ileal stenosis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Graft infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Transplant failure | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Wound secretion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Angioplasty | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Aortic aneurysm repair | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Peripheral endarterectomy | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Leriche syndrome | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Peripheral ischemia | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
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| 12 Months |
|
|
| Category 2, moderate claudication |
|
| Category 3, severe claudication |
|
| Category 4, ischemic rest paint |
|
| Category 5, minor tissue loss |
|
| Category 6, major tissue loss |
|
| 6 Months |
|
|
| 12 Months |
|
|
| Title | Measurements |
|---|---|
|
| Any MALE or POD |
|