A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch

Stroke Clinical Trial

Official title:

A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643743
• Other study ID #: 2020-POL-01
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: June 10, 2022

Study information

• Verified date: August 2022
• Source: Perouse Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Artery Stenosis
• Artery Stenosis, Carotid
• Carotid Stenosis
• Constriction, Pathologic
• Occlusion of Artery
• Stroke

Intervention

Device:
• Endarterectomy
Endarterectomy is a surgical procedure to remove the atheromatous plaque material, or blockage, in the lining of an artery constricted by the buildup of deposits. It is carried out by separating the plaque from the arterial wall.

Locations

Country	Name	City	State
France	Eclevar Medtech	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Perouse Medical	ECLEVAR MEDTECH

Country where clinical trial is conducted

France, 

Outcome

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