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

NCT03271710 | Completed DMC

• 1 other identifier: CSP1121
• Study Type: interventional
• Target: 113
• Locations: 2 countries
• Sites: 9

Brief Summary

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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Atherosclerosis of Femoral Artery

Keywords

Distal embolization; Percutaneous transluminal angioplasty; Integrated embolic protection

Outcome Measures

Primary Outcomes (2)

• Freedom from MAE, defined as death, amputation and target vessel revascularization (TVR)

  Primary safety endpoint

  30 days

• Procedural success

  Defined as \<50% residual stenosis without MAE (death, amputation or TVR)

  24 hours or at discharge.

Secondary Outcomes (3)

• Technical Success

  Index procedure

• Ankle-Brachial Index (ABI)

  Baseline, discharge and 30 days

• Rutherford-Becker

  30 days

Other Outcomes (1)

• Histomorphometric analysis of embolic protection filter content

  Day 0. Filter collected at end of index procedure.

Study Arms (1)

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

Device: peripheral balloon angioplasty

Interventions

peripheral balloon angioplasty DEVICE

Percutaneous transluminal angioplasty (PTA) of the lower extremities

Also known as: percutaneous transluminal angioplasty (PTA)

Peripheral balloon angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Contego Medical, Inc.: lead

Study Sites (9)

OLV Hospital Aalst

Aalst, 9300, Belgium

Location

Imelda Hospital / Vascular Science Research Center

Bonheiden, 2820, Belgium

Location

AZ Sint Blasius

Dendermonde, 9300, Belgium

Location

RZ Heilig Hart Hospital

Tienen, 3300, Belgium

Location

Interventional Cardiology and Vascular Medicine, Department of Angiology, Universitäts-Herzzentrum Freiburg

Bad Krozingen, 79189, Germany

Location

Sankt Gertrauden-Krankenhaus

Berlin, 10713, Germany

Location

Daikonissenkrankenhaus Flensburg

Flensburg, 24939, Germany

Location

MVZ/Prof. Mathey Prof. Schofer Clinic

Hamburg, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Thomas Zeller, Prof.

  Universitäts-Herzzentrum Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: September 5, 2017
• Study Start: September 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: December 30, 2018
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); BE (4)