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Evaluation of FUSION™ Vascular Graft for Above Knee Targets
NA trial testing FUSION Vascular Graft in Peripheral Arterial Occlusive Disease (PAOD) in 117 participants. Terminated before completion.
| Lead sponsor | Maquet Cardiovascular |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 117 |
| Start date | 26 October 2009 |
| Primary completion | 24 July 2013 |
| Estimated completion | 24 July 2013 |
| Sites | 10 locations across Austria, Germany |
Maquet Cardiovascular — full company profile →
Adults 18 to 85, any sex, with Peripheral Arterial Occlusive Disease (PAOD). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| FUSION Vascular Graft | 89 |
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.
| Group | Value | 95% CI |
|---|---|---|
| FUSION Vascular Graft | 96 |
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.
| Group | Value | 95% CI |
|---|---|---|
| FUSION Vascular Graft | 0.97 | ± 0.157 |
| Group | Value | 95% CI |
|---|---|---|
| FUSION Vascular Graft | 0.94 | ± 0.210 |
| Group | Value | 95% CI |
|---|---|---|
| FUSION Vascular Graft | 0.91 | ± 0.216 |
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).
| Group | Value | 95% CI |
|---|---|---|
| FUSION Vascular Graft | 65 | |
| FUSION Vascular Graft | 30 | |
| FUSION Vascular Graft | 8 | |
| FUSION Vascular Graft | 3 |
| Group | Value | 95% CI |
|---|---|---|
| FUSION Vascular Graft | 67 | |
| FUSION Vascular Graft | 23 | |
| FUSION Vascular Graft | 3 | |
| FUSION Vascular Graft | 1 |
| Group | Value | 95% CI |
|---|---|---|
| FUSION Vascular Graft | 68 | |
| FUSION Vascular Graft | 20 | |
| FUSION Vascular Graft | 7 | |
| FUSION Vascular Graft | 3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| FUSION Vascular Graft | 0 |
| Group | Value | 95% CI |
|---|---|---|
| FUSION Vascular Graft | 0 |
| Group | Value | 95% CI |
|---|---|---|
| FUSION Vascular Graft | 15 |
| Group | Value | 95% CI |
|---|---|---|
| FUSION Vascular Graft | 15 |
Time frame: Through 12 months follow up. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | FUSION Vascular Graft |
|---|---|---|
| Vascular graft occlusion | Injury, poisoning and procedural complications | — |
| Wound infection | Infections and infestations | — |
| Haematoma | Vascular disorders | — |
| Seroma | Injury, poisoning and procedural complications | — |
| Ileal stenosis | Gastrointestinal disorders | — |
| Impaired healing | General disorders | — |
| Oedema peripheral | General disorders | — |
| Aortic stenosis | Vascular disorders | — |
| Peripheral ischemia | Vascular disorders | — |
| Cardiac Failure | Cardiac disorders | — |
| Gallstone ileus | Gastrointestinal disorders | — |
| Death | General disorders | — |
| Renal failure | Renal and urinary disorders | — |
| Graft infection | Infections and infestations | — |
| Infection | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Post procedural haematoma | Injury, poisoning and procedural complications | — |
| Transplant failure | Injury, poisoning and procedural complications | — |
| Wound secretion | Injury, poisoning and procedural complications | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Angioplasty | Surgical and medical procedures | — |
| Aortic aneurysm repair | Surgical and medical procedures | — |
| Peripheral endarterectomy | Surgical and medical procedures | — |
| Surgery | Surgical and medical procedures | — |
Most-reported serious reactions: Vascular graft occlusion, Wound infection, Haematoma, Seroma, Ileal stenosis, Impaired healing, Oedema peripheral, Aortic stenosis.
Data from ClinicalTrials.gov NCT01601496 adverse events section.
The purpose of the post-market study was to evaluate the safety and performance of the FUSION Vascular Graft.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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