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

Not Applicable

Completed

• Conditions: Peripheral Arterial Vascular Occlusion
• Interventions: Device: dCell Vascular Patch

• Registration Number: NCT00958230
• Lead Sponsor: Tissue Regenix Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Primary Completion: 2010-04
• Status Verified: 2010-09
• Study Completion: 2011-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Patients scheduled for a remote or open peripheral vascular endarterectomy
2. Lack of suitable autologous material to function as closure patch for the arteriotomy
3. Uncomplicated standard elective endarterectomy procedure (per-operative inclusion criteria)
4. Use of dCell™ Vascular Patch as arteriotomy closure material (per-operative inclusion criteria)
5. Patients between 18 and 80 years old, inclusive
6. Haemoglobin > 9 g/dL and platelet count > 100,000/mm3 prior to Day 1
7. Other haematological and biochemical parameters within a range acceptable for the administration of general anesthesia prior to Day 1
8. Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
9. Duly executed, written, informed consent obtained from patient

Exclusion Criteria

1. Known serious allergy to contrast agent used for angiography
2. Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
3. 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
4. Patients receiving a revision of an existing graft
5. Patients demonstrating an active local or systemic infection (WBC > 15,000/mm3)
6. Any condition which in the judgment of the Investigator would preclude adequate evaluation of dCell™ Vascular Patch's safety and performance
7. Patients on vitamin K antagonists

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dCell Vascular Patch	dCell Vascular Patch	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.

Primary Outcome Measures

Name	Time	Method
Maintenance of Arterial Patency	6 months for CE Mark, 24 months Post Market Surveillance

Secondary Outcome Measures

Name	Time	Method
Complication Rate	6 months for CE Mark, 24 months for PMS

Trial Locations

Locations (4)

Semmelweis University Hospital; 🇭🇺 Semmelweis, Hungary

Szent Imre Hospital; 🇭🇺 Budapest, Hungary

Saint Elisabeth Hospital; 🇳🇱 Otrobanda, Curacao, Netherlands

Miskolc Hospital; 🇭🇺 Miskolc, Hungary