A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter (SLC)

LeMaitre Vascular

Status: Enrolling

Conditions: Arterial Thromboembolism

Treatments: Device: TufTex Single Lumen Embolectomy Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05386277

EC-16-001

Details and patient eligibility

About

A post market clinical study to confirm the performance and safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter on patients undergoing surgical treatment for the removal of arterial emboli and/or thrombi

Full description

This prospective, single arm, post market clinical study was designed to proactively collect clinical data on the LeMaitre® TufTex Single Lumen 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. This post market study is sponsored by LeMaitre® Vascular, Inc., the manufacturer of the device. Study will take place at 3 to 8 sites in Europe, the target sample size is 112 patients.

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 arterial or venous emboli and/or thrombi, 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 comprised

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

LeMaitre TufTex Single Lumen Embolectomy Catheter

Other group

Description:

The LeMaitre® Single Lumen Embolectomy Catheter is a catheter that consists of a natural latex rubber balloon secured with ligatures to a single lumen radiopaque shaft. When the balloon the emboli and/or thrombi can be removed by withdrawing the catheter tip through the arteriotomy.

Treatment:

Device: TufTex Single Lumen Embolectomy Catheter