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

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ClinicalTrials.gov Identifier: NCT02678065
Recruitment Status : Unknown
Verified August 2018 by Flanders Medical Research Program.
Recruitment status was:  Recruiting
First Posted : February 9, 2016
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: InPact Admiral DEB Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: InPact Admiral
Patients treated with the InPact Admiral balloon for popliteal lesions
Device: InPact Admiral DEB



Primary Outcome Measures :
  1. Primary Patency at 12 months [ Time Frame: 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.


Secondary Outcome Measures :
  1. Technical success [ Time Frame: 1 day post-op ]
    defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%.

  2. Primary Patency at 1 and 6-months [ Time Frame: 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

  3. Clinical success at 1, 6 and 12-months [ Time Frame: 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

  4. Serious Adverse Events [ Time Frame: up to 12 months ]
    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

  5. Survival rate [ Time Frame: up to 12 months ]
    all-cause death ratio

  6. Target Lesion Revascularization [ Time Frame: up to 12 months ]
    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

  7. Limb Salvage Rate [ Time Frame: up to 12 months ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678065


Contacts
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Contact: Jeroen Wauters +32 52 25 28 22 office@fmrp.be

Locations
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Belgium
Imelda Hospital Recruiting
Bonheiden, Antwerp, Belgium, 2820
Contact: Wendy Janssens    +3215506182    wendy.janssens@fmrp.be   
Principal Investigator: Patrick Peeters, MD         
Sub-Investigator: Jürgen Verbist, MD         
Sub-Investigator: Koen Keirse, MD         
A.Z. Sint-Blasius Recruiting
Dendermonde, East-Flanders, Belgium, 9200
Contact: Marc Bosiers, MD    +32 52 25 28 22    marc.bosiers@telenet.be   
Sub-Investigator: Koen Deloose, MD         
Sub-Investigator: Joren Callaert, MD         
OLV Aalst Recruiting
Aalst, Oost-Vlaanderen, Belgium, 9300
Contact: Lieven Maene, MD    +32 53 72 46 99    lmaene@hotail.com   
Principal Investigator: Lieven Maene, MD         
Sub-Investigator: Roel Beelen, MD         
RZ Heilig Hart Hospital Recruiting
Tienen, Belgium, 3300
Contact: Koen Keirse, MD    +32 16 80 99 72    keirsekoen@hotmail.com   
Principal Investigator: Koen Keirse, MD         
Sponsors and Collaborators
Flanders Medical Research Program
Investigators
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Principal Investigator: Marc Bosiers, MD Flanders Medical Research Program
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Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT02678065    
Other Study ID Numbers: FMRP-120524
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases