Arterial Thromboembolism
Conditions
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.
Interventions
DEVICETufTex Single Lumen Embolectomy Catheter
The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi
Sponsors
Avania
LeMaitre Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance objective is the technical success as defined as <30% residual stenosis | 1 month post index procedure | The primary performance objective is the technical success as defined as \<30% residual stenosis of the target vessel. |
| Safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure | During procedure and 1 month post index procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2. Revision Rate | 1 month post index procedure | Revision rate is defined as the number of patients with target vessel reintervention |
| 4. Secondary Patency | 1 month post index procedure | 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. |
| 3. Primary Assisted Patency | 1 month post index procedure | 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. Clinical success | 1 Month after the index procedure | 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 (2) Revision rate is defined as the number of patients with target vessel reintervention (3) 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. (4) 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory endpoints | 1 month post index procedure | Number of LeMaitre® Embolectomy Catheters used per intervention Number of balloon tears per intervention. |
Countries
Belgium, Germany, Switzerland
Contacts
Primary ContactAndrew Hodgkinson
Backup ContactBrian Orrick
Outcome results
None listed