Clinical trial NCT00958230: dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission
Official title: An Open Arm Pilot Study to Evaluate the Safety and Performance of the dCell Vascular Patch in Reconstructive Peripheral Vascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Vascular Occlusion
Keywords: endarterectomy
dCell
Tissue Regenix Ltd
TRL
Vascular Patch
Treatment
Lead sponsor: Tissue Regenix Ltd
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
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

Primary outcomes:
measure: Maintenance of Arterial Patency
timeFrame: 6 months for CE Mark, 24 months Post Market Surveillance
Secondary outcomes:
measure: Complication Rate
timeFrame: 6 months for CE Mark, 24 months for PMS
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Szent Imre Hospital
city: Miskolc
country: Hungary
facility: Miskolc Hospital
city: Semmelweis
country: Hungary
facility: Semmelweis University Hospital
city: Otrobanda
country: Netherlands
facility: Saint Elisabeth Hospital
state: Curacao
Study officials:
affiliation: Tissue Regenix Ltd
name: Keith Summerhayes, BSc (Hons)
role: STUDY_DIRECTOR
References: