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

In.Pact Flexion, a Physician Initiated Trial Investigating the Performance of the In.Pact Admiral Drug-eluting Balloon for the Treatment of Popliteal Lesions

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

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: InPact Admiral DEB

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Tienen, Belgium, 3300
    • Recruiting
    • RZ Heilig Hart Hospital
    • Contact: Koen Keirse, MD; Phone Number: +32 16 80 99 72; Email: keirsekoen@hotmail.com
  • Antwerp
    • Bonheiden, Antwerp, Belgium, 2820
      • Recruiting
      • Imelda Hospital
      • Contact: Wendy Janssens; Phone Number: +3215506182; Email: wendy.janssens@fmrp.be
      • Sub-Investigator: Jürgen Verbist, MD
      • Sub-Investigator: Koen Keirse, MD
  • East-Flanders
    • Dendermonde, East-Flanders, Belgium, 9200
      • Recruiting
      • A.Z. Sint-Blasius
      • Sub-Investigator: Joren Callaert, MD
      • Contact: Marc Bosiers, MD; Phone Number: +32 52 25 28 22; Email: marc.bosiers@telenet.be
      • Sub-Investigator: Koen Deloose, MD
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • Recruiting
      • OLV Aalst
      • Principal Investigator: Lieven Maene, MD
      • Sub-Investigator: Roel Beelen, MD
      • Contact: Lieven Maene, MD; Phone Number: +32 53 72 46 99; Email: lmaene@hotail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: InPact Admiral; Patients treated with the InPact Admiral balloon for popliteal lesions	Device: InPact Admiral DEB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency at 12 months	defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%.	1 day post-op
Primary Patency at 1 and 6-months	defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within the time of procedure and the given follow-up	1 and 6 months
Clinical success at 1, 6 and 12-months	defined as an improvement of Rutherford classification at 1-, 6- and 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification	1, 6 and 12 months
Serious Adverse Events	defined as a clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization	up to 12 months
Survival rate	all-cause death ratio	up to 12 months
Target Lesion Revascularization	defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge	up to 12 months
Limb Salvage Rate	defined as absence of major amputation. Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot)	up to 12 months

Collaborators and Investigators

• Sponsor: Flanders Medical Research Program
• Investigators: Principal Investigator: Marc Bosiers, MD, Flanders Medical Research Program

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: FMRP-120524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED