Peripheral Vascular DiseasePERFORMNCT02418156

A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction

An observational study of Peripheral Vascular Disease, run by Elutia Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery. Read more about this study

Who is it for?: Any age
Conditions the study is for: Peripheral Vascular Disease
What is being tested?: CorMatrix ECM for Vascular Repair
Type of treatment: Medical device
How many people: 38 participants
Where: No sites listed yet
Study dates: May 2015to Mar 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients presenting for femoral arterial reconstruction with patch angioplasty.

Who may be able to join

Subjects must be undergoing femoral arterial reconstruction with patch angioplasty closure
Surgeon intends to use CorMatrix ECM per FDA cleared Indications for Use
Subject possesses ability to provide informed consent
Subject expresses understanding and willingness to fulfill all expected requirements of protocol

Who cannot join

1. Known sensitivity to porcine material

About this study

Official title: A Post Market Observational Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction

To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.

Read the detailed description

OBJECTIVE The objective of the study is to actively gather additional information on the use of CorMatrix ECM for vascular repair in the reconstruction of the femoral artery. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.

Conditions: Peripheral Vascular Disease
Being tested: CorMatrix ECM for Vascular Repair
Medical subject headings: Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CorMatrix ECM for Vascular RepairDevice
Standard femoral arterial interventional procedure using CorMatrix ECM for vascular repair.

Study groups in NCT02418156
Study group	Role	What they receive
Single Arm		Subjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair. Receives: Device: CorMatrix ECM for Vascular Repair

What is being measured

The primary outcome is the main question the study is designed to answer.

Device-Related Adverse Events
Proportion of patients experiencing device related adverse events.
Measured: Up to 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Mar 2018

First posted16 Apr 2015 (estimated)
Study startMay 2015
Primary completionMar 2018
Study completionMar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral Vascular DiseaseStudies 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02418156
Sponsor's protocol ID: 14-PR-1120
Acronym: PERFORM
Status last verified: Jul 2023
First submitted: 9 Apr 2015
Last updated: 21 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Peripheral Vascular Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post Market Observational Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction
ClinicalTrials.gov ID: NCT02418156
Acronym / sponsor ID: PERFORM / 14-PR-1120
Conditions: Peripheral Vascular Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Elutia Inc.Industry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Mar 2018 (actual)
Study completion: Mar 2018 (actual)
First posted: 16 Apr 2015 (estimated)
Results: Posted 11 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Single Arm	–	Device: CorMatrix ECM for Vascular RepairSubjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients presenting for femoral arterial reconstruction with patch angioplasty.

Key inclusion criteria (4 listed)

Subjects must be undergoing femoral arterial reconstruction with patch angioplasty closure
Surgeon intends to use CorMatrix ECM per FDA cleared Indications for Use
Subject possesses ability to provide informed consent
Subject expresses understanding and willingness to fulfill all expected requirements of protocol

Key exclusion criteria (1 listed)

1. Known sensitivity to porcine material

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
CorMatrix ECM for Vascular RepairStandard femoral arterial interventional procedure using CorMatrix ECM for vascular repair.	Device	Single Arm

Primary outcome

Device-Related Adverse Events
Time frame: Up to 12 months follow-up
Proportion of patients experiencing device related adverse events.

Results and safety

Results posted to the registry on 11 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm	38	21

Primary outcome: Device-Related Adverse Events

Time frame: Up to 12 months follow-up. Number (95% Confidence Interval). Unit: Proportion of Participants that Experien

Measure	Single Arm n = 38
Value	0 (0 to 0)

Population analysed: Several participants had both limbs treated resulting in a greater number of procedures than participants analyzed.

Adverse events

Time frame: One year. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm	14 of 38 (36.8%)	0 of 38 (0%)	2 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Vascular Disease

Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Vascular Disease, run by Elutia Inc..

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 4 inclusion and 1 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 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Device-Related Adverse Events (time frame: Up to 12 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02418156.

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 21 Jul 2023.