Arteriovenous Shunting for Blood Access Clinical Trial
Official title:
A Retrospective Patient Registry on the Long-Term Safety and Performance of the LifeSpan® ePTFE Vascular Graft Used in Open Vascular Surgery
| Verified date | September 2023 |
| Source | LeMaitre Vascular |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.
| Status | Active, not recruiting |
| Enrollment | 177 |
| Est. completion date | December 2024 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Subject has undergone surgical treatment with the LifeSpan. - Surgical treatment was for bypass or reconstruction of diseased or occluded blood vessels (PVP group) or arteriovenous shunting for blood access (AV group). - For PVP group: Subject's surgical treatment was at minimum 3 years ago, and maximum 10 years ago, at time of enrollment. - For AV group: Subject's surgical treatment was at minimum 2 years ago, and maximum 10 years ago, at time of enrollment. Exclusion Criteria: - None |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum Nordfriesland GmbH | Husum |
| Lead Sponsor | Collaborator |
|---|---|
| LeMaitre Vascular |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of vessels patent without requiring intervention to remain open | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up | 3 years | |
| Primary | Percentage of vessels patent without requiring intervention to remain open | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up | 2 years | |
| Secondary | Procedure type | Type of procedure | Day of procedure | |
| Secondary | Intra-operative technical success | Percentage of patients with proper functioning of the device in the opinion of the investigator at time of surgery | Day of procedure | |
| Secondary | Percentage of vessels patent without requiring intervention to remain open at 1 and 5 year primary patency | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up | 1 year and 5 year | |
| Secondary | Percentage of vessels patent with intervention to remain open at 1 and 5 year | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions | 1 year and 5 year | |
| Secondary | Percentage of vessels patent with intervention to remain open at 1 and 5 year for AV Access | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions | 2 year | |
| Secondary | Percentage of vessels patent with intervention to remain open at 1 and 5 year for PVP Group | Percentage of patients exempt from thrombosis/ occlusion and/or restenosis of the target lesion during follow-up after interventions | 3 year |