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

NCT ID: NCT00958230

Last Updated: 2014-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-11-30

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.

Conditions

Peripheral Arterial Vascular Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

dCell Vascular Patch

Intervention Type: DEVICE

Implantation of a dCell Vascular Patch as part of an Endarterectomy

Interventions

dCell Vascular Patch

Implantation of a dCell Vascular Patch as part of an Endarterectomy

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tissue Regenix Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith Summerhayes, BSc (Hons)

Role: STUDY_DIRECTOR

Tissue Regenix Ltd

Locations

Szent Imre Hospital

Budapest, , Hungary

Miskolc Hospital

Miskolc, , Hungary

Semmelweis University Hospital

Semmelweis, , Hungary

Saint Elisabeth Hospital

Otrobanda, Curacao, Netherlands

Countries

Hungary; Netherlands

Other Identifiers

TRL P001-09

Identifier Type: -

Identifier Source: org_study_id