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

NCT02678065 | Unknown Phase 4 DMC

• 1 other identifier: FMRP-120524
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Technical success

  1 day post-op

• Primary Patency at 1 and 6-months

  1 and 6 months

• Clinical success at 1, 6 and 12-months

  1, 6 and 12 months

• Serious Adverse Events

  up to 12 months

• Survival rate

  up to 12 months

Study Arms (1)

InPact Admiral

EXPERIMENTAL

Patients treated with the InPact Admiral balloon for popliteal lesions

Device: InPact Admiral DEB

Interventions

InPact Admiral DEB DEVICE

InPact Admiral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (4)

Imelda Hospital

Bonheiden, Antwerp, 2820, Belgium

RECRUITING

A.Z. Sint-Blasius

Dendermonde, East-Flanders, 9200, Belgium

RECRUITING

OLV Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

RECRUITING

RZ Heilig Hart Hospital

Tienen, 3300, Belgium

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Marc Bosiers, MD

  Flanders Medical Research Program

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeroen Wauters

CONTACT

+32 52 25 28 22; office@fmrp.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 9, 2016
• Study Start: April 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

BE (4)