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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2027-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Thrombus Embolus Occlusion; Vessel

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LeMaitre TufTex Over-the-Wire Embolectomy Catheter

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.

Group Type OTHER

TufTex Over-the-Wire Embolectomy Catheter

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No