Peripheral Arterial DiseaseENTRAPNCT03271710

Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the Vanguard IEP System

A study testing peripheral balloon angioplasty in people with Peripheral Arterial Disease and Intermittent Claudication, run by Contego Medical, Inc. at 9 sites in 2 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Disease, Intermittent Claudication, Atherosclerosis of Femoral Artery
What is being tested?: peripheral balloon angioplasty
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 9 sitesin 2 countries
Study dates: 1 Sep 2017to 30 Dec 2018
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients ≥18 years old.
Subject has clinically significant symptomatic leg ischemia requiring treatment.
Subject has a Rutherford category of 2 - 3.
Target lesion in the superficial femoral artery (SFA), common femoral artery, p1 segment of popliteal artery, common iliac artery and external iliac artery (cross-over access only), and profunda femoris arteries.
Target lesion stenosis >50% by investigator's visual estimate.
Vessel diameter between 4.0 mm and 8.0 mm at the site of the target lesion.

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Total target lesion length ≤ 18 cm, and may include a chronic total occlusion ≤ 10 cm.
If target lesion is restenotic, the prior PTA must be > 30 days prior to enrollment.
If the guide wire traverses the lesion subintimally, it must enter the true lumen distal to the lesion without the use of a reentry device.
Distal vessel diameter at the site of filter deployment of 4.0 mm to 8.0 mm with sufficient landing zone required for the successful deployment of the integrated embolic protection filter.
Patent popliteal and infrapopliteal arteries; I.e. single vessel runoff or better with at least one of three vessels patient (<50% stenosis) to the ankle or foot.
The patient (or legally authorized representative) is willing to provide written informed consent and to comply with all study requirements.

Who cannot join

Subjects who have undergone prior vascular surgery of the target artery to treat atherosclerotic disease.
History of major amputation in the same limb as the target lesion.
Woman who is pregnant or nursing.
Subject has Rutherford category of 4- 6.
Target lesion(s) within native or synthetic vessel grafts.
Use of atherectomy as an adjunctive therapy during the index procedure in the target lesion or target vessel.

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Any major (e.g. cardiac, peripheral, abdominal) intervention, including in the contralateral lim planned within 30 days post index procedure.
Presence of other hemodynamically significant outflow lesion in the target limb requiring intervention within 30 days of enrollment.
Subject has significant inflow disease which cannot be treated prior to target lesion treatment.
Presence of aneurysm in the target vessel.
Acute limb occlusion due to thrombotic occlusion of the target limb.
In-stent restenosis of target lesion.
Severe calcification that renders the target lesion lesion resistant to angioplasty.
Visible acute thrombus in the target lesion
Intolerance to antiplatelet, anticoagulant or thrombolytic therapy medications that would be administered during the trial.
Known hypersensitivity to contrast media that cannot be adequately premedicated.
Known hypersensitivity to nickel and/or titanium.
Acute Myocardial Infarction within 30 days prior to the index procedure.
Subject has a known coagulopathy or bleeding diathesis, or INR <1.5.
Platelet count <100,000 mm3/L or >700,000 mm3/L
Concomitant renal failure with a serum creatinine > 2.5 mg/dL or receiving dialysis.
Patient is currently participating in an interventional study, investigational drug or device study that has not completed the primary endpoint, that may potentially confound the results of this trial or that would limit the subject's compliance with the follow-up requirements.

Trial locations and contacts

9 sites in 2 countries.

Country

City, postcode or hospital

9 sites in 2 countries

Germany5 sites

Interventional Cardiology and Vascular Medicine, Department of Angiology, Universitäts-Herzzentrum Freiburg
Bad Krozingen, 79189
Sankt Gertrauden-Krankenhaus
Berlin, 10713
Daikonissenkrankenhaus Flensburg
Flensburg, 24939
MVZ/Prof. Mathey Prof. Schofer Clinic
Hamburg
Universitätsklinikum Leipzig
Leipzig, 04103

Other trials in Germany

Belgium4 sites

OLV Hospital Aalst
Aalst, 9300
Imelda Hospital / Vascular Science Research Center
Bonheiden, 2820
AZ Sint Blasius
Dendermonde, 9300
RZ Heilig Hart Hospital
Tienen, 3300

Other trials in Belgium

About this study

Official title: A Single-Arm, Multicenter Study for the Lower Extremities Using the Vanguard IEP Peripheral Balloon Angioplasty System With Integrated Embolic Protection

The ENTRAP Study is a prospective, multi-center, non-randomized, single-arm, study with follow-up to 30 days to determine the acute safety, acute device performance and clinical performance of the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection. The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for peripheral vascular percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal and profunda arteries.

Read the detailed description

The Vanguard System has been designed to revascularize iliac and femoro-popliteal PAD while protecting against embolization at the same time. It is the first system in which the embolic protection filter is coupled on the same catheter as the angioplasty balloon for use in the lower extremities. Up to 130 patients will be enrolled into this study and followed for 30 days after post-procedure. Adult patients with lifestyle-limiting claudication or rest pain (Rutherford categories 2 to 3) who meet all eligibility criteria will be approached for participation in the trial.

Conditions: Peripheral Arterial Disease, Intermittent Claudication, Atherosclerosis of Femoral Artery
Being tested: peripheral balloon angioplasty
Keywords: Distal embolization, Percutaneous transluminal angioplasty, Integrated embolic protection
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.

peripheral balloon angioplastyDevice
Also called percutaneous transluminal angioplasty (PTA)
Percutaneous transluminal angioplasty (PTA) of the lower extremities

Study groups in NCT03271710
Study group	Role	What they receive
Peripheral balloon angioplasty	Experimental	Peripheral vascular percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal and profunda arteries with the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection Receives: Device: peripheral balloon angioplasty

What is being measured

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

Freedom from MAE, defined as death, amputation and target vessel revascularization (TVR)
Primary safety endpoint
Measured: 30 days
Procedural success
Defined as <50% residual stenosis without MAE (death, amputation or TVR)
Measured: 24 hours or at discharge.

Secondary outcomes (3)

Technical Success
Technical success of the investigational device using questionnaire
Measured: Index procedure
Ankle-Brachial Index (ABI)
Change in Ankle-Brachial Index from baseline, discharge and 30 days
Measured: Baseline, discharge and 30 days
Rutherford-Becker
Rutherford-Becker improvement greater than or equal to 1
Measured: 30 days

Timeline

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

1 Sep 201730 Dec 2018

First posted5 Sep 2017
Study start1 Sep 2017
Primary completion30 Nov 2018
Study completion30 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03271710
Sponsor's protocol ID: CSP1121
Acronym: ENTRAP
Status last verified: Jul 2019
First submitted: 26 Apr 2017
Last updated: 10 Jul 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Site specific individual participant data is available to each research site via export from EDC.

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 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Arm, Multicenter Study for the Lower Extremities Using the Vanguard IEP Peripheral Balloon Angioplasty System With Integrated Embolic Protection
ClinicalTrials.gov ID: NCT03271710
Acronym / sponsor ID: ENTRAP / CSP1121
Conditions: Peripheral Arterial Disease, Intermittent Claudication, Atherosclerosis of Femoral Artery
Keywords: Distal embolization, Percutaneous transluminal angioplasty, Integrated embolic protection
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: Contego Medical, Inc.Industry (pharma, biotech, devices)
Study start: 1 Sep 2017 (actual)
Primary completion: 30 Nov 2018 (actual)
Study completion: 30 Dec 2018 (actual)
First posted: 5 Sep 2017 (actual)
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.

Detailed description

Study design

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

Arm	Type	Receives
Peripheral balloon angioplasty	Experimental	Device: peripheral balloon angioplastyPeripheral vascular percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal and profunda arteries with the Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

Who may qualify

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

Key inclusion criteria (12 listed)

Male and female patients ≥18 years old.
Subject has clinically significant symptomatic leg ischemia requiring treatment.
Subject has a Rutherford category of 2 - 3.
Target lesion in the superficial femoral artery (SFA), common femoral artery, p1 segment of popliteal artery, common iliac artery and external iliac artery (cross-over access only), and profunda femoris arteries.
Target lesion stenosis >50% by investigator's visual estimate.

Key exclusion criteria (22 listed)

Subjects who have undergone prior vascular surgery of the target artery to treat atherosclerotic disease.
History of major amputation in the same limb as the target lesion.
Woman who is pregnant or nursing.
Subject has Rutherford category of 4- 6.
Target lesion(s) within native or synthetic vessel grafts.

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
peripheral balloon angioplastyAlso: percutaneous transluminal angioplasty (PTA)Percutaneous transluminal angioplasty (PTA) of the lower extremities	Device	Peripheral balloon angioplasty

Primary outcome

Freedom from MAE, defined as death, amputation and target vessel revascularization (TVR)
Time frame: 30 days
Primary safety endpoint
Procedural success
Time frame: 24 hours or at discharge.
Defined as <50% residual stenosis without MAE (death, amputation or TVR)

3 secondary outcomes

Technical Success
Time frame: Index procedure
Ankle-Brachial Index (ABI)
Time frame: Baseline, discharge and 30 days
Rutherford-Becker
Time frame: 30 days

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 10 Jul 2019.
Individual participant dataSharing planned: No. Site specific individual participant data is available to each research site via export from EDC.

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.

Thomas Zeller, Prof. principal investigator

Universitäts-Herzzentrum Freiburg

9 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing peripheral balloon angioplasty in people with Peripheral Arterial Disease and Intermittent Claudication, run by Contego Medical, Inc. at 9 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 12 inclusion and 22 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany, Belgium. 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?

Freedom from MAE, defined as death, amputation and target vessel revascularization (TVR) (time frame: 30 days). 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?

On the ClinicalTrials.gov record for NCT03271710.

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 10 Jul 2019.