Peripheral Arterial DiseasesNCT02066740
EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study
A study testing EverFlex™ stent with Entrust™ delivery system in people with Peripheral Arterial Diseases, run by Medtronic Endovascular at 1 site in Germany.
Trial summary
The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Diseases
- What is being tested?
- EverFlex™ stent with Entrust™ delivery system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Jul 2014
- 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
- Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts),
- or occluded lesion(s) located in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) suitable for primary stenting.
Who cannot join
- Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.
- Conditions
- Peripheral Arterial Diseases
- Being tested
- EverFlex™ stent with Entrust™ delivery system
- Keywords
- Superficial Femoral Artery, Proximal Popliteal Artery, Everflex, Entrust, stent
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverFlex™ stent with Entrust™ delivery systemDevice
| Study group | Role | What they receive |
|---|---|---|
| EverFlex™ stent with Entrust™ delivery system | Experimental | Not described Receives: Device: EverFlex™ stent with Entrust™ delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Stent Elongation
Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length
Measured: Intra operative
Successful Stent Deployment
Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
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 DiseasesStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl M Wahlgren, MD/PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066740
- Sponsor's protocol ID
- CP1007
- Status last verified
- Feb 2019
- First submitted
- 16 Feb 2014
- Last updated
- 1 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study
- ClinicalTrials.gov ID
- NCT02066740
- Acronym / sponsor ID
- CP1007
- Conditions
- Peripheral Arterial Diseases
- Keywords
- Superficial Femoral Artery, Proximal Popliteal Artery, Everflex, Entrust, stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Posted 16 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EverFlex™ stent with Entrust™ delivery system | Experimental | Device: EverFlex™ stent with Entrust™ delivery system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts),
- or occluded lesion(s) located in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) suitable for primary stenting.
Key exclusion criteria (1 listed)
- Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.
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 |
|---|---|---|
| EverFlex™ stent with Entrust™ delivery system | Device | EverFlex™ stent with Entrust™ delivery system |
Primary outcome
Absence of Stent Elongation
Time frame: Intra operative
Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length
Successful Stent Deployment
Time frame: Procedure
Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carl M Wahlgren, MD/PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EverFlex™ stent with Entrust™ delivery system in people with Peripheral Arterial Diseases, run by Medtronic Endovascular at 1 site in Germany.
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 2 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 1 Mar 2019. 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 Germany. 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 16 Sep 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?
Absence of Stent Elongation (time frame: Intra operative). The study lists 2 primary outcomes in all. 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 1 Mar 2019.