Randomized Study of IN.PACT 014 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter vs. Optimal Percutaneous Transluminal Angioplasty for the treatment of chronic total occlusions in the infrapopliteal arteries.

Withdrawn

• Conditions: chronic total occlusions in the infrapopliteal arteries; 10003216

• Registration Number: NL-OMON46468
• Lead Sponsor: Medtronic B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 8

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 <=7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses).
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 the 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 (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 <=30% per visual assessment. If an inflow lesion must be treated within the P3 segment of the popliteal artery, there must be a minimum of 3 cm healthy tissue between this (treated) lesion and the infrapopliteal target lesion.
13. Successful pre-dilatation of the (entire) target lesion. Success being documented by angiographic visual estimate of <=30% Residual diameter stenosis of the target lesion and by functional assessment of the distal flow by intra-operative Doppler: recording of biphasic or triphasic wave signal with rapid take-off distal to the target lesion.

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 <=30% residual stenosis in pre-existing, hemodynamically significant (>=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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the efficacy of the IN.PACT 014 by comparing the Late Lumen Loss<br /><br>(LLL) 9 months after the index procedure of the investigational product vs<br /><br>optimal (conventional) PTA</p><br>