A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TufTex Single Lumen Embolectomy Catheter.
- Who it may be relevant to
- Registry conditions: Arterial Thromboembolism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Germany, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device TufTex Single Lumen Embolectomy Catheter
The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi
Primary outcome measures
- 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]
- Performance objective is the technical success as defined as <30% residual stenosis [Time frame: 1 month post index procedure]
Secondary outcome measures (4)
- 1. Clinical success [Time frame: 1 Month after the index procedure]
- 2. Revision Rate [Time frame: 1 month post index procedure]
- 3. Primary Assisted Patency [Time frame: 1 month post index procedure]
- 4. Secondary Patency [Time frame: 1 month post index procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Belgium · 1 center
- Ziekenhuis Oost-Limburg — Genk
Germany · 1 center
- Andrej Udelnow — Brandenburg
Switzerland · 1 center
- Giorgio Prouse — Lugano
Identifiers
NCT: NCT05386277 · EC-16-001