Peripheral Arterial Vascular Occlusion Clinical Trial
Official title:
An Open Arm Pilot Study to Evaluate the Safety and Performance of the dCell Vascular Patch in Reconstructive Peripheral Vascular Surgery
| Verified date | September 2010 |
| Source | Tissue Regenix Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Hungary: National Institute of Pharmacy |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | November 2011 |
| Est. primary completion date | April 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Hungary | Szent Imre Hospital | Budapest | |
| Hungary | Miskolc Hospital | Miskolc | |
| Hungary | Semmelweis University Hospital | Semmelweis | |
| Netherlands | Saint Elisabeth Hospital | Otrobanda | Curacao |
| Lead Sponsor | Collaborator |
|---|---|
| Tissue Regenix Ltd |
Hungary, Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maintenance of Arterial Patency | 6 months for CE Mark, 24 months Post Market Surveillance | No | |
| Secondary | Complication Rate | 6 months for CE Mark, 24 months for PMS | Yes |