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

Peripheral Arterial Disease Clinical Trial

— INPCTFLEXION  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02678065
• Other study ID #: FMRP-120524
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2014
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Flanders Medical Research Program
• Contact: Jeroen Wauters
• Phone: +32 52 25 28 22
• Email: office[@]fmrp.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• InPact Admiral DEB

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst	Oost-Vlaanderen
Belgium	Imelda Hospital	Bonheiden	Antwerp
Belgium	A.Z. Sint-Blasius	Dendermonde	East-Flanders
Belgium	RZ Heilig Hart Hospital	Tienen

Sponsors (1)

Lead Sponsor	Collaborator
Flanders Medical Research Program

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Survival rate	all-cause death ratio	up to 12 months
Secondary	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
Secondary	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