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NCT Number: NCT05386277

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

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

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Key information

Conditions

Arterial Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg, Genk, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

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 comprised

Treatment and study plan

TufTex Single Lumen Embolectomy Catheter

Device

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

Primary outcomes

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

    Time frame: During procedure and 1 month post index 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.

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

    Time frame: 1 month post index procedure

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

Secondary outcomes

  1. 1. Clinical success

    Time frame: 1 Month after the index procedure

    Clinical success is target vessel dependent and defined as; (1) The absence of target vessel limb amputation post-intervention in case of limb cloths, and 2. successful dialysis sessions performed post-intervention in case of dialysis shunt revascularization (2) Revision rate is defined as the number of patients with target vessel reintervention (3) Primary assisted patency is defined as target vessel patency; the target vessel is patent but there may have been some intervention required to maintain that patency. (4) Secondary patency is defined as the target vessel patency including target vessel that have been occluded and there has been an intervention to restore patency.

  2. 2. Revision Rate

    Time frame: 1 month post index procedure

    Revision rate is defined as the number of patients with target vessel reintervention

  3. 3. Primary Assisted Patency

    Time frame: 1 month post index procedure

    Primary assisted patency is defined as target vessel patency; the target vessel is patent but there may have been some intervention required to maintain that patency.

  4. 4. Secondary Patency

    Time frame: 1 month post index procedure

    Secondary patency is defined as the target vessel patency including target vessel that have been occluded and there has been an intervention to restore patency.

Other outcomes

  1. Exploratory endpoints

    Time frame: 1 month post index procedure

    Number of LeMaitre® Embolectomy Catheters used per intervention Number of balloon tears per intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Hodgkinson

CONTACT

[email protected]

781-425-1664

Brian Orrick

CONTACT

[email protected]

7814251685

Sponsors and collaborators

Lead sponsor

LeMaitre Vascular

Industry

Collaborators

  • Avania

Registry information

Official study title

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

Acronym: SLC

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 23, 2022
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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