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

Flanders Medical Research Program

Status and phase

Unknown

Phase 4

Conditions

Peripheral Arterial Disease

Treatments

Device: InPact Admiral DEB

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT02678065

FMRP-120524

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.