Clinical trial NCT05386342: A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters
Official title: A Post-market Clinical Study to Confirm the Performance and Safety of the LeMaitre TufTex Over-the-Wire (OTW) 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: Thrombus
Embolus
Occlusion; Vessel
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: TREATMENT

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

Detailed description: This clinical investigation is a prospective, single-arm, multicenter, post-market study to proactively collect clinical data on the LeMaitre® TufTex Over-the-Wire (OTW) 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. The intended purpose of the device in this post market clinical study is identical to the indication of use of the device.

The TufTex OTW post-market study is initiated by the Sponsor and manufacturer of the device, LeMaitre Vascular, Inc.

The investigation will take place in 4 sites, most likely in 3 different countries. A total number of 112 subjects is anticipated to be enrolled, who are intended to undergo surgical treatment for the removal of a emboli and/or thrombi. The anticipated enrollment period is 48 months, and the participation per subject is 1 month. The total study duration is expected to be 56 months (4 months start-up, 48 months of recruitment, 1 month of follow-up, 3 months of closure.

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 an emboli or thrombi during an embolectomy and/or thrombectomy procedure, 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 compromised

Primary outcomes:
measure: Performance objective is the technical success being <30% residual stenosis
timeFrame: 1 month post index procedure
measure: Safety objective is defined as acceptable safety outcomes during the procedure and at follow-up
timeFrame: 1 month post index procedure
Secondary outcomes:
measure: 1.Clinical success
timeFrame: 1 month post 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: Brandenburg
country: Germany
facility: Andrej Udelnow
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus TU Dresden
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano - sede Civico
Study officials:
affiliation: Ospedale Regionale di Lugano - sede Civico
name: Giorgio Prouse, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Brandenburg
name: Andrej Udelnow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Carl Gustav Carus
name: Sandra Korn, MD
role: PRINCIPAL_INVESTIGATOR
References: