A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters

Official title

A Post-market Clinical Study to Confirm the Performance and Safety of the LeMaitre TufTex Over-the-Wire (OTW) Embolectomy Catheter on Patients Undergoing Surgical Treatment for the Removal of Arterial Emboli and/or Thrombi

Overview

A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter

Detailed description

This clinical investigation is a prospective, single-arm, multicenter, post-market study to proactively collect clinical data on the LeMaitre® TufTex Over-the-Wire (OTW) Embolectomy Catheters and to confirm its performance in removing arterial emboli and/or thrombi, to identify and analyze emergent risks on the basis of factual evidence, and to ensure the continued acceptability of the benefit/risk ratio. The intended purpose of the device in this post market clinical study is identical to the indication of use of the device.

The TufTex OTW post-market study is initiated by the Sponsor and manufacturer of the device, LeMaitre Vascular, Inc.

The investigation will take place in 4 sites, most likely in 3 different countries. A total number of 112 subjects is anticipated to be enrolled, who are intended to undergo surgical treatment for the removal of a emboli and/or thrombi. The anticipated enrollment period is 48 months, and the participation per subject is 1 month. The total study duration is expected to be 56 months (4 months start-up, 48 months of recruitment, 1 month of follow-up, 3 months of closure.

Interventions

• Device TufTex Over-the-Wire Embolectomy Catheter
  The OTW Catheter can be used for the removal of emboli and thrombi. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.

Primary outcome measures

• Performance objective is the technical success being <30% residual stenosis [Time frame: 1 month post index procedure]
• Safety objective is defined as acceptable safety outcomes during the procedure and at follow-up [Time frame: 1 month post index procedure]

Secondary outcome measures (4)

• 1.Clinical success [Time frame: 1 month post index procedure]
• 2. Revision rate [Time frame: 1 month post index procedure]
• 3. Primary assisted patency [Time frame: 1 month post index procedure]
• 4. Secondary patency [Time frame: 1 month post index procedure]

Eligibility criteria

Inclusion criteria

• Male and female subject, ≥ 18 years of age at time of enrollment.
• Subject who is scheduled to undergo surgical treatment for the removal of an emboli or thrombi during an embolectomy and/or thrombectomy procedure, where one of the LeMaitre® Embolectomy Catheter will be used.
• Subject signed an Informed Consent for participation.
• Subject diagnosed with a embolus/thrombus.
• Subjects for whom thrombolytic therapy had failed or was contraindicated.

Exclusion criteria

• Co-morbidity that in the discretion of the investigator might confound the results.
• Subjects who are unable to read or write.
• Pregnant or lactating women at time of enrollment
• Subjects who are immune compromised

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 2 centers

• Andrej Udelnow — Brandenburg
• University Hospital Carl Gustav Carus TU Dresden — Dresden

Switzerland · 1 center

• Ospedale Regionale di Lugano - sede Civico — Lugano

Identifiers

NCT: NCT05386342 · EC-16-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗