Stroke Clinical Trial
Official title:
A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch
NCT number | NCT04643743 |
Other study ID # | 2020-POL-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2020 |
Est. completion date | June 10, 2022 |
Verified date | August 2022 |
Source | Perouse Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population. All data will be retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery. A minimum of 250 up to a maximum of 300 subjects will be evaluated from 3 to 8 different sites. At least 100 subjects will be evaluated in carotid location and at least 100 in femoral location.
Status | Completed |
Enrollment | 198 |
Est. completion date | June 10, 2022 |
Est. primary completion date | June 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Subjects who did receive POLYPATCH® at least one year ago for vascular angioplasty - Subjects = 18 years old Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
France | Eclevar Medtech | Paris |
Lead Sponsor | Collaborator |
---|---|
Perouse Medical | ECLEVAR MEDTECH |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change rate of restenosis | Measure assessing change target-artery restenosis (defined as 70% or more diameter-reducing stenosis), occlusion, or re-intervention within 1 year after surgery using POLYPATCH® | within 30 days after surgery and long term (up to 1 year after surgery ) | |
Secondary | Procedural success rate | ability to use with no need for using another device,
effective vascular closure after endarterectomy procedure, no need to re-operate before patient discharge |
within 30 days after surgery and long term (up to 1 year after surgery ) | |
Secondary | target-artery restenosis Target-artery restenosis | Restenosis can be identified by echo-doppler, CT scan or angiography evaluating the percentage of lumen of vessel but can also be classified as symptomatic vs asymptomatic and/or requiring or not re-intervention. | within 30 days after surgery and long term (up to 3 years) | |
Secondary | target-artery re-intervention | angioplasty and stenting,
surgical bypass, thrombectomy and re-do patchoplasty, evacuation of hematoma. |
within 30 days after surgery and long term (up to 3 years) | |
Secondary | stroke (ipsilateral and any) | Stroke is a risk inherent to any surgical intervention, especially vascular surgeries. Although uncommon, stroke in the perioperative period is associated with significant morbidity and mortality in the CEA patient population | within 30 days after surgery and long term (up to 3 years) | |
Secondary | transient ischemic attack | within 30 days after surgery and long term (up to 3 years) | 3 years | |
Secondary | myocardial infarction | within 30 days after surgery and long term (up to 3 years) | 3 years | |
Secondary | mortality (cardiovascular and all causes) | Death is the most dramatic complication one can encounter after vascular procedure. It can result from ipsilateral stroke caused by restenosis or thrombi, patch rupture caused by patch infection, or secondary cardiovascular or neurologic risks caused by the surgery itself | within 30 days after surgery and long term (up to 3 years) | |
Secondary | occurrence of other complications | within 30 days after surgery and long term (up to 3 years) | within 30 days after surgery and long term (up to 3 years) | |
Secondary | Operation time | up to 24 weeks |
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