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

LeMaitre Vascular

Status: Enrolling

Conditions: Embolus; Occlusion; Vessel; Thrombus

Treatments: Device: TufTex Over-the-Wire Embolectomy Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05386342

EC-16-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female subject, ≥ 18 years of age at time of enrollment.
2. 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.
3. Subject signed an Informed Consent for participation.
4. Subject diagnosed with a embolus/thrombus.
5. Subjects for whom thrombolytic therapy had failed or was contraindicated.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

LeMaitre TufTex Over-the-Wire Embolectomy Catheter

Other group

Description:

The LeMaitre Over the Wire Embolectomy Catherer is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.

Treatment:

Device: TufTex Over-the-Wire Embolectomy Catheter