NCT05386342

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2023Jun 2027

First Submitted

Initial submission to the registry

May 10, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

4.4 years

First QC Date

May 10, 2022

Last Update Submit

October 16, 2024

Conditions

ThrombusEmbolusOcclusion; Vessel

Outcome Measures

Primary Outcomes (2)

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

    The primary performance objective of the study is the technical success as defined as \<30% residual stenosis of the target vessel as evaluated on the completion digital subtraction angiography (DSA).

    1 month post index procedure

  • Safety objective is defined as acceptable safety outcomes during the procedure and at follow-up

    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.

    1 month post index procedure

Secondary Outcomes (4)

  • 1.Clinical success

    1 month post 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 Over-the-Wire Embolectomy Catheter

OTHER

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.

Device: TufTex Over-the-Wire Embolectomy Catheter

Interventions

TufTex Over-the-Wire Embolectomy CatheterDEVICE

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.

LeMaitre TufTex Over-the-Wire Embolectomy Catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 an emboli or thrombi during an embolectomy and/or thrombectomy procedure, 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 compromised

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Andrej Udelnow

Brandenburg, Germany

RECRUITING

University Hospital Carl Gustav Carus TU Dresden

Dresden, Germany

NOT YET RECRUITING

Ospedale Regionale di Lugano - sede Civico

Lugano, Switzerland

RECRUITING

MeSH Terms

Conditions

ThrombosisEmbolismBites and Stings

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Giorgio Prouse, MD

    Ospedale Regionale di Lugano - sede Civico

    PRINCIPAL INVESTIGATOR

  • Andrej Udelnow, MD

    University of Brandenburg

    PRINCIPAL INVESTIGATOR

  • Sandra Korn, MD

    University Hospital Carl Gustav Carus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Hodgkinson

CONTACT

781-425-1664ahodgkinson@lemaitre.com

Brian Orrick

CONTACT

781-425-1685borrick@lemaitre.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
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, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

October 18, 2024

Record last verified: 2024-10

Locations

DE(2)CH(1)