dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission

Study Overview
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Brief Summary
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The study is designed to produce early safety and performance data in a small group of patients requiring repair of a peripheral vascular endarterectomy (incision into an artery feeding the limbs which requires a patch to repair the incision after removal of an atherosclerotic plaque that was stopping usual blood flow to the limbs). Data is being collected to show the procedure is safe and allows for normal blood flow to be resumed. Data will be used to facilitate CE Mark submission.

Official Title
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An Open Arm Pilot Study to Evaluate the Safety and Performance of the dCell Vascular Patch in Reconstructive Peripheral Vascular Surgery

Conditions
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Peripheral Arterial Vascular Occlusion

Intervention / Treatment
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* Device: dCell Vascular Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for a remote or open peripheral vascular endarterectomy Lack of suitable autologous material to function as closure patch for the arteriotomy Uncomplicated standard elective endarterectomy procedure (per-operative inclusion criteria) Use of dCell™ Vascular Patch as arteriotomy closure material (per-operative inclusion criteria) Patients between 18 and 80 years old, inclusive Haemoglobin > 9 g/dL and platelet count > 100,000/mm3 prior to Day 1 Other haematological and biochemical parameters within a range acceptable for the administration of general anesthesia prior to Day 1 Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures Duly executed, written, informed consent obtained from patient Exclusion Criteria: Known serious allergy to contrast agent used for angiography Treatment with any investigational drug or device within 60 days prior to study entry (Day 1) If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months Patients receiving a revision of an existing graft Patients demonstrating an active local or systemic infection (WBC > 15,000/mm3) Any condition which in the judgment of the Investigator would preclude adequate evaluation of dCell™ Vascular Patch's safety and performance Patients on vitamin K antagonists

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dCell Vascular Patch<br>This Xenograft device is manufactured from Porcine Pericardium Tissue which has been decellularised leaving a scaffold style structure for ingrowth of human endothelial cells after placement into the operative site. | Device: dCell Vascular Patch<br>* Implantation of a dCell Vascular Patch as part of an Endarterectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of Arterial Patency |  | 6 months for CE Mark, 24 months Post Market Surveillance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rate |  | 6 months for CE Mark, 24 months for PMS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endarterectomy, dCell, Tissue Regenix Ltd, TRL, Vascular Patch, Treatment