LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry

NCT04620889 | Completed FDA Device

• 1 other identifier: LFP-15-001
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.

Conditions

Diseased or Occluded Blood Vessels; Arteriovenous Shunting for Blood Access

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Procedure type

  Day of procedure

• Intra-operative technical success

  Day of procedure

• Percentage of vessels patent without requiring intervention to remain open at 1 and 5 year primary patency

  1 year and 5 year

• Percentage of vessels patent with intervention to remain open at 1 and 5 year

  1 year and 5 year

• Percentage of vessels patent with intervention to remain open at 1 and 5 year for AV Access

  2 year

Study Arms (2)

PVP (peripheral vascular disease)

Bypass or reconstruction of diseased or occluded blood vessels

Device: PVP

AV Access (arteriovenous access)

Arteriovenous shunting for blood access and bypass.

Device: AV Access

Interventions

AV Access DEVICE

Arteriovenous shunting for blood access.

AV Access (arteriovenous access)

PVP DEVICE

Bypass or reconstruction of diseased or occluded blood vessels

PVP (peripheral vascular disease)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective registry. The included population is therefore directly representative of the population in a real-world environment.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• LeMaitre Vascular: lead

Study Sites (1)

Klinikum Nordfriesland GmbH

Husum, Germany

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: November 27, 2020
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)