Clinical trial NCT02963649: IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA
Official title: Randomized Study of IN.PACT 014 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter vs. Standard Percutaneous Transluminal Angioplasty for the Treatment of Chronic Total Occlusions in the Infrapopliteal Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Limb Ischemia
Peripheral Arterial Disease
Keywords: Drug-eluting angioplasty balloon, Drug coated angioplasty balloon, Experimental, percutaneous transluminal angioplasty (PTA)
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2016-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety and efficacy of the paclitaxel drug-eluting balloon IN.PACT 014 versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Subject has been informed of the nature of the study, agrees to participate and has signed an EC approved consent form.
3. Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation.
4. Subject has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Clinical Category 4 or 5.
5. Subjects with documented infection grade 0-2 and ischemia grade 2-3 according to WIfi classification.
6. Life expectancy \>1 year in the Investigator's opinion.
7. Reference Vessel Diameter (RVD) 2 - 4 mm, and confirmed by DUS assessment.
8. Total occlusions with total lesion length ≥ 40 mm.
9. Lesion must be located in the infrapopliteal arteries and above the ankle joint.
10. Multiple lesions can be treated if located in separate vessels.
11. Presence of documented run-off to the foot.
12. Inflow free from flow-limiting lesion confirmed by angiography.
13. Successful pre-dilatation of the (entire) target lesion.

Exclusion Criteria:

1. Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study.
2. Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre or post-procedure.
3. Lesion and/or occlusions located or extending in the popliteal artery or below the ankle joint space.
4. Significant inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries left untreated.
5. Failure to obtain ≤ 30% residual stenosis in pre-existing, hemodynamically significant inflow lesions in the ipsilateral iliac, SFA and popliteal artery.
6. Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization.
7. Previous DCB procedure in the target vessel within 6 months prior to index procedure.
8. Aneurysm in the target vessel.
9. Angiographic evidence of thrombus within target limb.
10. Pre-dilatation resulted in major (≥ Grade D) flow-limiting dissection or residual stenosis \> 30%.
11. Use of alternative therapy e.g. atherectomy, cutting balloon, laser, radiation therapy, stents as part of target vessel treatment.
12. Recent MI or stroke \< 30 days prior to the index procedure.
13. Heart failure with Ejection Fraction \< 30%.
14. Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound on the target limb.
15. Subjects with infection grade 3 and ischemia grade 0 and 1 according to the Wifi classification.
16. Subjects with neutrotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk of major amputation.
17. Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement.
18. Impaired renal function (GFR \<20 mL/min) and patients on dialysis.
19. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment.
20. Patient receiving systemic corticosteroid therapy.
21. Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
22. The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.
23. Female subjects who are breastfeeding at the time of enrollment.

Primary outcomes:
measure: Efficacy: Late lumen loss (LLL) at 9 months
timeFrame: 9 Months
Secondary outcomes:
measure: Composite Safety Endpoint
timeFrame: 30 days and 9 Months
measure: Major Adverse Event (MAE) rate
timeFrame: through 3, 6, 9, 12, 24, 36, 48 and 60 months
measure: Status of wound healing
timeFrame: at 30 days, 3, 6, 9, 12, 24 and 36 months
measure: Rate of thrombosis at the target lesion
timeFrame: through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months
measure: Device success
timeFrame: at the time of procedure
measure: Clinical success
timeFrame: up to discharge visit
measure: Functional flow assessment
timeFrame: at 3, 6, 9, 12, 24 and 36 months
measure: Death of any cause and cardiovascular-related deaths
timeFrame: through 3, 6, 9, 12, 24, 36, 48 and 60 months
measure: Major Target Limb Amputation rate
timeFrame: through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months
measure: Mechanically-driven Target Lesion Revascularization (TLR) rate
timeFrame: through 37 days
measure: Target Lesion Revascularization (TLR) rate
timeFrame: through 3, 6, 9, 12, 24, 36, 48 and 60 months
measure: Clinically-driven Target Lesion Revascularization (CD-TLR) rate
timeFrame: through 3, 6, 9, 12, 24, 36, 48 and 60 months
measure: Target Vessel Revascularization (TVR) rate
timeFrame: through 3, 6, 9, 12, 24, 36, 48 and 60 months
measure: Clinically-driven Target Vessel Revascularization (CD-TVR) rate
timeFrame: through 3, 6, 9, 12, 24, 36, 48 and 60 months
Other outcomes:
Locations:
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
state: East-Flanders
city: Genk
country: Belgium
facility: ZOL Genk
state: Limburg
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Nantes
country: France
facility: Hopital Guillaume et Rene Laennec - Centre Hospitalier Universitaire
city: Patras
country: Greece
facility: University Hospital Patras
city: Sesto San Giovanni
country: Italy
facility: IRCCS Multimedica
state: Lombardy
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
city: Arezzo
country: Italy
facility: Ospedale San Donato
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
citation: Liistro F, Weinberg I, Almonacid Popma A, Shishehbor MH, Deckers S, Micari A. Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial. EuroIntervention. 2022 Apr 1;17(17):e1445-e1454. doi: 10.4244/EIJ-D-21-00444.