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

NCT05386277 | Recruiting DMC FDA Device

• 1 other identifier: EC-16-001
• Study Type: interventional
• Target: 112
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Arterial Thromboembolism

Outcome Measures

Primary Outcomes (2)

• Safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure

  The primary safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure and 1 Month post index procedure.

  During procedure and 1 month post index procedure

• Performance objective is the technical success as defined as <30% residual stenosis

  The primary performance objective is the technical success as defined as \<30% residual stenosis of the target vessel.

  1 month post index procedure

Secondary Outcomes (4)

• 1. Clinical success

  1 Month after the index procedure

• 2. Revision Rate

  1 month post index procedure

• 3. Primary Assisted Patency

  1 month post index procedure

• 4. Secondary Patency

  1 month post index procedure

Other Outcomes (1)

• Exploratory endpoints

  1 month post index procedure

Study Arms (1)

LeMaitre TufTex Single Lumen Embolectomy Catheter

OTHER

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.

Device: TufTex Single Lumen Embolectomy Catheter

Interventions

TufTex Single Lumen Embolectomy Catheter DEVICE

The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi

LeMaitre TufTex Single Lumen Embolectomy Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 comprised

Sponsors & Collaborators

• LeMaitre Vascular: lead
• Avania: collaborator

Study Sites (3)

Ziekenhuis Oost-Limburg

Genk, Belgium

RECRUITING

Andrej Udelnow

Brandenburg, Germany

RECRUITING

Giorgio Prouse

Lugano, Switzerland

NOT YET RECRUITING

Study Officials

• Giorgio Prouse

  Ospedale Regionale di Lugano - sede Civico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Hodgkinson

CONTACT

781-425-1664; ahodgkinson@lemaitre.com

Brian Orrick

CONTACT

7814251685; borrick@lemaitre.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 23, 2022
• Study Start: January 11, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); CH (1); BE (1)