Peripheral Arterial DiseasePhase 4INPCTFLEXIONNCT02678065
In.Pact Flexion, Investigating the Performance of the In.Pact Admiral DEB for Popliteal Lesions
A Phase 4 study testing InPact Admiral DEB in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 4 sites in Belgium.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- InPact Admiral DEB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesBelgium
- Study dates
- Apr 2014to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
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- 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.
Who cannot join
- - 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
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- 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.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites, 4 recruiting
- Recruiting
OLV Aalst
Aalst, Oost-Vlaanderen, 9300
Lieven Maene, MD, +32 53 72 46 99, lmaene@hotail.com
Lieven Maene, MD
- Recruiting
Imelda Hospital
Bonheiden, Antwerp, 2820
Wendy Janssens, +3215506182, wendy.janssens@fmrp.be
Patrick Peeters, MD
- Recruiting
A.Z. Sint-Blasius
Dendermonde, East-Flanders, 9200
Marc Bosiers, MD, +32 52 25 28 22, marc.bosiers@telenet.be
Koen Deloose, MD
- Recruiting
RZ Heilig Hart Hospital
Tienen, 3300
Koen Keirse, MD, +32 16 80 99 72, keirsekoen@hotmail.com
Koen Keirse, MD
About this study
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
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
- Being tested
- InPact Admiral DEB
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InPact Admiral DEBDevice
| Study group | Role | What they receive |
|---|---|---|
| InPact Admiral | Experimental | Patients treated with the InPact Admiral balloon for popliteal lesions Receives: Device: InPact Admiral DEB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
Technical success
defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%.
Measured: 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
Measured: 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
Measured: 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
Measured: up to 12 months
Survival rate
all-cause death ratio
Measured: 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
Measured: 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)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startApr 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flanders Medical Research Program
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marc Bosiers, MD, Principal investigator, Flanders Medical Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678065
- Sponsor's protocol ID
- FMRP-120524
- Acronym
- INPCTFLEXION
- Status last verified
- Aug 2018
- First submitted
- 4 Feb 2016
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02678065
- Acronym / sponsor ID
- INPCTFLEXION / FMRP-120524
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Flanders Medical Research ProgramResearch network
- Study start
- Apr 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InPact Admiral | Experimental | Device: InPact Admiral DEBPatients treated with the InPact Admiral balloon for popliteal lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- - 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
Key exclusion criteria (15 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InPact Admiral DEB | Device | InPact Admiral |
Primary outcome
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.
7 secondary outcomes
Technical success
Time frame: 1 day post-op
Primary Patency at 1 and 6-months
Time frame: 1 and 6 months
Clinical success at 1, 6 and 12-months
Time frame: 1, 6 and 12 months
Serious Adverse Events
Time frame: up to 12 months
Survival rate
Time frame: up to 12 months
Target Lesion Revascularization
Time frame: up to 12 months
Limb Salvage Rate
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Bosiers, MD principal investigator
Flanders Medical Research Program
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing InPact Admiral DEB in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeroen Wauters (+32 52 25 28 22, office@fmrp.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.