Status:
COMPLETED
dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission
Lead Sponsor:
Tissue Regenix Ltd
Conditions:
Peripheral Arterial Vascular Occlusion
Eligibility:
All Genders
18-80 years
Phase:
NA
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 whic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00958230
Start Date
August 1 2009
End Date
November 1 2011
Last Update
November 14 2014
Active Locations (4)
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1
Szent Imre Hospital
Budapest, Hungary, H-1115
2
Miskolc Hospital
Miskolc, Hungary, H-3501
3
Semmelweis University Hospital
Semmelweis, Hungary, H-1122
4
Saint Elisabeth Hospital
Otrobanda, Curacao, Netherlands