Clinical trial NCT05386277: A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arterial Thromboembolism
Lead sponsor: LeMaitre Vascular
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2022-05-23
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure
timeFrame: During procedure and 1 month post index procedure
measure: Performance objective is the technical success as defined as <30% residual stenosis
timeFrame: 1 month post index procedure
Secondary outcomes:
measure: 1. Clinical success
timeFrame: 1 Month after the index procedure
measure: 2. Revision Rate
timeFrame: 1 month post index procedure
measure: 3. Primary Assisted Patency
timeFrame: 1 month post index procedure
measure: 4. Secondary Patency
timeFrame: 1 month post index procedure
Other outcomes:
measure: Exploratory endpoints
timeFrame: 1 month post index procedure
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Brandenburg
country: Germany
facility: Andrej Udelnow
city: Lugano
country: Switzerland
facility: Giorgio Prouse
Study officials:
affiliation: Ospedale Regionale di Lugano - sede Civico
name: Giorgio Prouse
role: PRINCIPAL_INVESTIGATOR
References: