Thrombus Clinical Trial
— OTWOfficial 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
NCT number | NCT05386342 |
Other study ID # | EC-16-002 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 11, 2023 |
Est. completion date | June 2027 |
A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter
Status | Recruiting |
Enrollment | 112 |
Est. completion date | June 2027 |
Est. primary completion date | June 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Andrej Udelnow | Brandenburg | |
Germany | University Hospital Carl Gustav Carus TU Dresden | Dresden | |
Switzerland | Ospedale Regionale di Lugano - sede Civico | Lugano |
Lead Sponsor | Collaborator |
---|---|
LeMaitre Vascular | Avania |
Germany, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory endpoints | Number of LeMaitre® TufTex OTW Embolectomy Catheters used per intervention | 1 month post index procedure | |
Primary | 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 | |
Primary | 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 | 1.Clinical success | 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 | 1 month post index procedure | |
Secondary | 2. Revision rate | Revision rate is defined as the number of patients with target vessel reintervention | 1 month post index procedure | |
Secondary | 3. Primary assisted patency | 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. | 1 month post index procedure | |
Secondary | 4. Secondary patency | 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 | 1 month post index procedure |
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