chronic total occlusions in the infrapopliteal arteries
Conditions
Interventions
The IN.PACT 014 is a medical device that contains an ancillary medicinal
substance. The product consists of an over-the-wire (OTW) balloon catheter with
a drug-coated balloon at the distal tip. The
Paclitaxel
Randomized Controlled Trial
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion 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 Ethics Committee (EC) approved consent form. 3. Female subjects of childbearing potential have a negative pregnancy test 1 year in the Investigator*s opinion. 7. Reference Vessel Diameter (RVD) 2 - 4 mm, and confirmed by DUS assessment. 8. Total occlusions (100% stenosis) with total lesion length >=40mm (by visual estimate). 9. The lesion must be located in the infrapopliteal arteries and above the ankle joint. Lesions may not extend above the tibioperoneal trunk (P3 segment of the popliteal artery) or below the ankle joint (arteries of the foot), nor can the treatment (investigational device or standard PTA, including pre-dilatation) extend beyond these indicated regions for more than 1 cm. Note: • A target lesion can extend into the P3 segment in case it involves a straight lesion extending from the target vessel. • Non-significant stenosis below the ankle joint can be allowed in case this is not part of the target lesion and does not require treatment 10. Multiple lesions can be treated if they are located in separate vessels but all lesions must meet the protocol specified criteria. 11. Presence of documented run-off to the foot (clearly visible dorsalis pedis, pedal arch or plantar arteries by angiography). Target vessel should give direct or indirect run-off to the foot 12. Inflow free from flow-limiting lesion confirmed by angiography. Patients with flow-limiting inflow lesions (>= 50% stenosis) can be included if lesion(s) have been treated successfully before enrollment, with a maximum residual stenosis of
Exclusion criteria
Exclusion criteria: 1. Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study. Note: the investigator should discuss the follow-up requirements extensively during the informed consent process to ensure that the subject is fully aware about the expectations and is willing to comply with the follow-up schedule. 2. Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre or post-procedure. A planned amputation including and below the metatarsal level (1 or multiple rays) is accepted. 3. Lesion and / or occlusions located or extending in the popliteal artery or below the ankle joint space. Note: • A target lesion can extend into the P3 segment in case it involves a straight lesion extending from the target vessel • Non-significant stenosis below the ankle joint can be allowed in case this is not part of the target lesion and does not require treatment. 4. Significant (>=50% DS) inflow lesion or occlusion in the ipsilateral Iliac, SFA and popliteal arteries left untreated. 5. Failure to obtain a =50% DS) inflow lesions in the ipsilateral iliac, SFA and popliteal artery. Inflow lesions should be treated per standard of care. 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-dilation resulted in a major (>= Grade D) flow-limiting dissection (observed on 2 orthogonal views) or residual stenosis >30%. 11. Use of alternative therapy, e.g. atherectomy, cutting balloon, laser, radiation therapy, stents as part of target vessel treatment. Note: Use of stents is only allowed for bailout stenting. 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 (abnormal white blood cell count, fever, sepsis or positive blood culture), excluding an infection of a lower extremity wound on the target limb (only WIfI infection grade 0-2 allowed). 15. Subjects with infection grade 3 and ischemia grade 0 and 1 according to WIfI classification. 16.Subjects with neurotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk for 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) or patients on dialysis. 19. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment. 20. Patient receiving systemic corticosteroid therapy (expected dosage exceeding 5mg of prednisolone or equivalent, per day during the initial 9 months after procedure). 21. This criteria has been removed 22. 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. 23. The patient is currently enrolled in another investigatio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of the IN.PACT 014 by comparing the Late Lumen Loss (LLL) 9 months after the index procedure of the investigational product vs optimal (conventional) PTA | — |
Secondary
| Measure | Time frame |
|---|---|
| • Composite Safety Endpoint: A composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation and freedom from clinically-driven TLR within 9 months post-index procedure. • Major Adverse Event (MAE) rate, defined as a composite of all-cause mortality, target limb major amputation and clinically-driven TLR through 3, 6, 9, 12, 24 and 36 months. • Functional flow assessment at 3, 6, 9, 12 and 24 month, defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound. • Death of any cause and cardiovascular related deaths through 3, 6, 9, 12 and 24 months. • Rate of major target limb amputation through 30 days, 3, 6, 9 ,12 and 24 months. • Rate of CD-TLR through 3, 6, 9, 12 and 24 months. • Rate of Mechanically Driven TLR through 30 days. • Rate of TLR through 3, 6, 9, 12 and 24 months. • Rate of CD-TVR through 3, 6, 9, 12 and 24 months. • Rate of TVR through 3, 6, 9, 12 and 24 months. • Status of wound healing (completely healed - improvement - unchanged - worsened) at 30 days, 3, 6, 9, 12 and 24 months. • Rate of thrombosis at the target lesion through 30 days, 3, 6, 9, 12 and 24 months. • Device success (for investigational device only) Device success is defined as successful drug delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP). • Clinical success Clinical success is defined as residual stenosis of | — |
Countries
The Netherlands
Outcome results
None listed