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

Primary Purpose

Peripheral Arterial Disease

Status

Unknown status

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

InPact Admiral DEB

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Imelda HospitalRecruiting
A.Z. Sint-BlasiusRecruiting
OLV AalstRecruiting
RZ Heilig Hart HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

InPact Admiral

Arm Description

Patients treated with the InPact Admiral balloon for popliteal lesions

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Technical success

defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%.

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

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

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

Survival rate

all-cause death ratio

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

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)

Full Information

NCT ID

NCT02678065

First Posted

February 4, 2016

Last Updated

August 10, 2018

Sponsor

Flanders Medical Research Program

1. Study Identification

Unique Protocol Identification Number

NCT02678065

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Flanders Medical Research Program

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

InPact Admiral

Arm Type

Experimental

Arm Description

Patients treated with the InPact Admiral balloon for popliteal lesions

Intervention Type

Device

Intervention Name(s)

InPact Admiral DEB

Primary Outcome Measure Information:

Title

Primary Patency at 12 months

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Technical success

Description

defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%.

Time Frame

1 day post-op

Title

Primary Patency at 1 and 6-months

Description

Time Frame

1 and 6 months

Title

Clinical success at 1, 6 and 12-months

Description

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

Time Frame

1, 6 and 12 months

Title

Serious Adverse Events

Description

Time Frame

up to 12 months

Title

Survival rate

Description

all-cause death ratio

Time Frame

up to 12 months

Title

Target Lesion Revascularization

Description

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

Time Frame

up to 12 months

Title

Limb Salvage Rate

Description

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeroen Wauters

Phone

+32 52 25 28 22

office@fmrp.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc Bosiers, MD

Organizational Affiliation

Flanders Medical Research Program

Official's Role

Principal Investigator

Facility Information:

Facility Name

Imelda Hospital

City

Bonheiden

State/Province

Antwerp

ZIP/Postal Code

2820

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wendy Janssens

Phone

+3215506182

wendy.janssens@fmrp.be

First Name & Middle Initial & Last Name & Degree

Patrick Peeters, MD

First Name & Middle Initial & Last Name & Degree

Jürgen Verbist, MD

First Name & Middle Initial & Last Name & Degree

Koen Keirse, MD

Facility Name

A.Z. Sint-Blasius

City

Dendermonde

State/Province

East-Flanders

ZIP/Postal Code

9200

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc Bosiers, MD

Phone

+32 52 25 28 22

marc.bosiers@telenet.be

First Name & Middle Initial & Last Name & Degree

Koen Deloose, MD

First Name & Middle Initial & Last Name & Degree

Joren Callaert, MD

Facility Name

OLV Aalst

City

Aalst

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9300

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lieven Maene, MD

Phone

+32 53 72 46 99

lmaene@hotail.com

First Name & Middle Initial & Last Name & Degree

Lieven Maene, MD

First Name & Middle Initial & Last Name & Degree

Roel Beelen, MD

Facility Name

RZ Heilig Hart Hospital

City

Tienen

ZIP/Postal Code

3300

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Koen Keirse, MD

Phone

+32 16 80 99 72

keirsekoen@hotmail.com

First Name & Middle Initial & Last Name & Degree

Koen Keirse, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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