In.Pact Flexion, Investigating the Performance of the In.Pact Admiral DEB for Popliteal Lesions

NCT ID: NCT02678065

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-12-31

Brief Summary

The objective of this study is to evaluate the performance of the In.Pact Admiral DEB for the treatment of popliteal lesions in comparison with literature results of stent treatment in popliteal lesions

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

InPact Admiral

Patients treated with the InPact Admiral balloon for popliteal lesions

Group Type: EXPERIMENTAL

InPact Admiral DEB

Intervention Type: DEVICE

Interventions

InPact Admiral DEB

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• - De novo, restenotic or reoccluded lesion located in the popliteal artery, with or without superficial femoral artery involvement
• Patient presenting a score from 2 to 5 following Rutherford classification
• Patient is willing to comply with specified follow-up evaluations at the specified times
• Patient is >18 years old
• Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Prior to enrollment, the guidewire has crossed target lesion
• Patient is eligible for treatment with the In.Pact Admiral drug-eluting balloon
• The target lesion, visually estimated, has a maximal length of 14 cm and can be categorized as either a type A or B lesion according the TASC II guidelines
• The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
• Target vessel diameter visually estimated is >3.5mm and <7.5 mm
• There is angiographic evidence of at least one vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention.

Exclusion Criteria

• - Presence of another stent in the target vessel that was placed during a previous procedure
• Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
• Previous by-pass surgery in the same limb
• Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
• Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
• Perforation at the angioplasty site evidenced by extravasation of contrast medium
• Patients with known hypersensitivity to nickel-titanium
• Patients with uncorrected bleeding disorders
• Aneurysm located at the level of the SFA and/or popliteal artery
• Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
• Life expectancy of less than twelve months
• Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis > 30% or ipsilateral iliac treatment conducted after the target lesion procedure
• Use of thrombectomy, atherectomy or laser devices during procedure
• Any patient considered to be hemodynamically unstable at onset of procedure
• Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

Flanders Medical Research Program

Locations

Imelda Hospital

Bonheiden, Antwerp, Belgium

Site Status: RECRUITING

A.Z. Sint-Blasius

Dendermonde, East-Flanders, Belgium

Site Status: RECRUITING

OLV Aalst

Aalst, Oost-Vlaanderen, Belgium

Site Status: RECRUITING

RZ Heilig Hart Hospital

Tienen, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jeroen Wauters

Role: CONTACT

office@fmrp.be

+32 52 25 28 22

Facility Contacts

Wendy Janssens

Role: primary

wendy.janssens@fmrp.be

+3215506182

Marc Bosiers, MD

Role: primary

marc.bosiers@telenet.be

+32 52 25 28 22

Lieven Maene, MD

Role: primary

lmaene@hotail.com

+32 53 72 46 99

Koen Keirse, MD

Role: primary

keirsekoen@hotmail.com

+32 16 80 99 72

Other Identifiers

FMRP-120524

Identifier Type: -

Identifier Source: org_study_id