Peripheral Arterial Vascular OcclusionNCT00958230
dCell Vascular Patch in Peripheral Vascular Surgery Study for CE Mark Submission
A study testing dCell Vascular Patch in people with Peripheral Arterial Vascular Occlusion, run by Tissue Regenix Ltd at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Vascular Occlusion
- What is being tested?
- dCell Vascular Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2009to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Hungary3 sites
Szent Imre Hospital
Budapest, H-1115
Miskolc Hospital
Miskolc, H-3501
Semmelweis University Hospital
Semmelweis, H-1122
About this study
Official title: An Open Arm Pilot Study to Evaluate the Safety and Performance of the dCell Vascular Patch in Reconstructive Peripheral Vascular Surgery
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
- Being tested
- dCell Vascular Patch
- Keywords
- endarterectomy, dCell, Tissue Regenix Ltd, TRL, Vascular Patch, Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dCell Vascular PatchDevice
Implantation of a dCell Vascular Patch as part of an Endarterectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: dCell Vascular Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of Arterial Patency
Measured: 6 months for CE Mark, 24 months Post Market Surveillance
Secondary outcomes (1)
Complication Rate
Measured: 6 months for CE Mark, 24 months for PMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Vascular OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tissue Regenix Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Summerhayes, BSc (Hons), Study director, Tissue Regenix Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958230
- Sponsor's protocol ID
- TRL P001-09
- Status last verified
- Sep 2010
- First submitted
- 11 Aug 2009
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Arm Pilot Study to Evaluate the Safety and Performance of the dCell Vascular Patch in Reconstructive Peripheral Vascular Surgery
- ClinicalTrials.gov ID
- NCT00958230
- Acronym / sponsor ID
- TRL P001-09
- Conditions
- Peripheral Arterial Vascular Occlusion
- Keywords
- endarterectomy, dCell, Tissue Regenix Ltd, TRL, Vascular Patch, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tissue Regenix LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dCell Vascular Patch | Experimental | Device: dCell Vascular PatchThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dCell Vascular PatchImplantation of a dCell Vascular Patch as part of an Endarterectomy | Device | dCell Vascular Patch |
Primary outcome
Maintenance of Arterial Patency
Time frame: 6 months for CE Mark, 24 months Post Market Surveillance
1 secondary outcome
Complication Rate
Time frame: 6 months for CE Mark, 24 months for PMS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Summerhayes, BSc (Hons) study director
Tissue Regenix Ltd
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dCell Vascular Patch in people with Peripheral Arterial Vascular Occlusion, run by Tissue Regenix Ltd at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hungary, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of Arterial Patency (time frame: 6 months for CE Mark, 24 months Post Market Surveillance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.