Peripheral Arterial DiseaseNCT01400919

DURABILITY™ Iliac Study

A study testing Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System. in people with Peripheral Arterial Disease and Claudication, run by Medtronic Endovascular at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

The DURABILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Protégé® EverFlex™ and Protégé® GPS™ Self-Expanding Stent Systems for the treatment of atherosclerotic lesions in the common and/or external iliac arteries. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Disease, Claudication
What is being tested?: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteUnited States
Study dates: Jul 2011to Jan 2016
Phase: Interventional
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or 4.
Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery.
Willing to comply with all follow-up evaluations at the specified times.
Provides written informed consent prior to enrollment in the study.

Who cannot join

Previous implantation of stent(s) in the target vessel.
Received endovascular treatment of the target lesion within six months prior to the index procedure.
Known hypersensitivity to contrast material that cannot be adequately pretreated.
Known hypersensitivity to nickel-titanium.
Life expectancy of less than 12 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Mount Sinai School of Medicine
New York, New York, 10029

Other trials in United States

About this study

Official title: Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ Iliac)

Conditions: Peripheral Arterial Disease, Claudication
Being tested: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.
Keywords: Peripheral arterial disease, claudication, stent, EverFlex, GPS, Iliac Artery
Medical subject headings: Peripheral Arterial Disease, Intermittent Claudication

What participants receive

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

Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.Device
Implantation of one or more study devices in the common and/or external iliac artery.

Study groups in NCT01400919
Study group	Role	What they receive
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems	Experimental	The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery. Receives: Device: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.

What is being measured

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

Major Adverse Event Rate
Measured: 9 months

Timeline

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

Jul 2011Jan 2016

First posted25 Jul 2011 (estimated)
Study startJul 2011
Primary completionNov 2013
Study completionJan 2016

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 Arterial 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01400919
Sponsor's protocol ID: P-5684
Status last verified: Feb 2018
First submitted: 21 Jul 2011
Last updated: 7 Mar 2018
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism

All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ Iliac)
ClinicalTrials.gov ID: NCT01400919
Acronym / sponsor ID: P-5684
Conditions: Peripheral Arterial Disease, Claudication
Keywords: Peripheral arterial disease, claudication, stent, EverFlex, GPS, Iliac Artery
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Medtronic EndovascularIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Nov 2013 (actual)
Study completion: Jan 2016 (actual)
First posted: 25 Jul 2011 (estimated)
Results: Posted 24 Jun 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems	Experimental	Device: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or 4.
Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery.
Willing to comply with all follow-up evaluations at the specified times.
Provides written informed consent prior to enrollment in the study.

Key exclusion criteria (5 listed)

Previous implantation of stent(s) in the target vessel.
Received endovascular treatment of the target lesion within six months prior to the index procedure.
Known hypersensitivity to contrast material that cannot be adequately pretreated.
Known hypersensitivity to nickel-titanium.
Life expectancy of less than 12 months

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
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.Implantation of one or more study devices in the common and/or external iliac artery.	Device	Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems

Primary outcome

Major Adverse Event Rate
Time frame: 9 months

Results and safety

Results posted to the registry on 24 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems	75	67

Primary outcome: Major Adverse Event Rate

Time frame: 9 months. Number. Unit: percentage of participants

Measure	Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems n = 75
Value	1.3

Adverse events

Time frame: All events that occured within 9 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems	29 of 75 (38.7%)	44 of 75 (58.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Arterial Disease

Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism

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.

Peter L. Faries, M.D. principal investigator

Icahn School of Medicine at Mount Sinai

John H. Rundback, M.D. principal investigator

Holy Name Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 24 Jun 2015). 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?

Major Adverse Event Rate (time frame: 9 months). 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 NCT01400919.

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 7 Mar 2018.