A Phase 4 interventional study of InPact Admiral DEB in Peripheral Arterial Disease, sponsored by Flanders Medical Research Program. Status unknown at 4 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-13.
Sponsored by Flanders Medical Research Program · Phase 4, Interventional, and Treatment
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
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 100 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Flanders Medical Research Program is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients treated with the InPact Admiral balloon for popliteal lesions
Device: InPact Admiral DEB
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.
Time frame: 12 months
Technical success
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
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
Time frame: 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
Time frame: 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
Time frame: up to 12 months
Survival rate
all-cause death ratio
Time frame: 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
Time frame: 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)
Time frame: up to 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Flanders Medical Research Program