IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-02

Study Completion Date

2023-12-21

Brief Summary

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

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Detailed Description

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Conditions

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Critical Limb Ischemia Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Drug Coated Balloon IN.PACT 014 (DCB)

Participants who receive IN.PACT 014.

Group Type EXPERIMENTAL

DCB

Intervention Type DEVICE

Drug Coated Balloon

Percutaneous Transluminal Angioplasty (PTA)

Participants who receive standard PTA treatment.

Group Type ACTIVE_COMPARATOR

PTA

Intervention Type DEVICE

Percutaneous Transluminal Angioplasty

Interventions

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DCB

Drug Coated Balloon

Intervention Type DEVICE

PTA

Percutaneous Transluminal Angioplasty

Intervention Type DEVICE

Eligibility Criteria

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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 (by visual estimate).
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 (≥50% DS) 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No