Clinical trial NCT02678065: In.Pact Flexion, Investigating the Performance of the In.Pact Admiral DEB for Popliteal Lesions
Official title: In.Pact Flexion, a Physician Initiated Trial Investigating the Performance of the In.Pact Admiral Drug-eluting Balloon for the Treatment of Popliteal Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2016-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Primary Patency at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: 1 day post-op
measure: Primary Patency at 1 and 6-months
timeFrame: 1 and 6 months
measure: Clinical success at 1, 6 and 12-months
timeFrame: 1, 6 and 12 months
measure: Serious Adverse Events
timeFrame: up to 12 months
measure: Survival rate
timeFrame: up to 12 months
measure: Target Lesion Revascularization
timeFrame: up to 12 months
measure: Limb Salvage Rate
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
state: Antwerp
city: Dendermonde
country: Belgium
facility: A.Z. Sint-Blasius
state: East-Flanders
city: Aalst
country: Belgium
facility: OLV Aalst
state: Oost-Vlaanderen
city: Tienen
country: Belgium
facility: RZ Heilig Hart Hospital
Study officials:
affiliation: Flanders Medical Research Program
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
References: