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

NCT00958230 | Completed

• 1 other identifier: TRL P001-09
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 4

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

Keywords

endarterectomy; dCell; Tissue Regenix Ltd; TRL; Vascular Patch; Treatment

Outcome Measures

Primary Outcomes (1)

• Maintenance of Arterial Patency

  6 months for CE Mark, 24 months Post Market Surveillance

Secondary Outcomes (1)

• Complication Rate

  6 months for CE Mark, 24 months for PMS

Study Arms (1)

dCell Vascular Patch

EXPERIMENTAL

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

Interventions

dCell Vascular Patch DEVICE

Implantation of a dCell Vascular Patch as part of an Endarterectomy

dCell Vascular Patch

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for a remote or open peripheral vascular endarterectomy
• Lack of suitable autologous material to function as closure patch for the arteriotomy
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tissue Regenix Ltd: lead

Study Sites (4)

Szent Imre Hospital

Budapest, H-1115, Hungary

Location

Miskolc Hospital

Miskolc, H-3501, Hungary

Location

Semmelweis University Hospital

Semmelweis, H-1122, Hungary

Location

Saint Elisabeth Hospital

Otrobanda, Curacao, Netherlands

Location

Study Officials

• Keith Summerhayes, BSc (Hons)

  Tissue Regenix Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 13, 2009
• Study Start: August 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: November 1, 2011
• Last Updated: November 14, 2014

Record last verified: 2010-09

Locations

HU (3); NL (1)