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

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease; Critical Limb Ischemia

• Registration Number: NCT02963649
• Lead Sponsor: Medtronic Endovascular

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-15
• Study Start: 2017-03-02
• Primary Completion: 2019-10-07
• Study Completion: 2023-12-21
• Results First Submitted: 2024-12-04
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-07
• Results First Posted: 2025-07-08
• Last Update Posted: 2025-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months	9 Months	Late lumen loss (LLL) - The difference between minimum lumen diameter (MLD) immediately after percutaneous balloon angioplasty PTA and MLD at follow up, measured at 9 months

Secondary Outcome Measures

Name	Time	Method
Composite Safety Endpoint	9 Months	A composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation and freedom from clinically-driven target lesion revascularization (CD-TLR) within 9 months post-index procedure
Major Adverse Event (MAE) Rate	through 3, 6, 9, 12, 24, 36, 48 and 60 months	defined as a composite of all-cause mortality, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR); Reported by using the event-free survival Kaplan-Meier estimate through 60 months
Functional Flow Assessment	at 3, 6, 9, 12, 24 and 36 months	is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound.
Death of Any Cause	through 3, 6, 9, 12, 24, 36, 48 and 60 months	Death of any cause, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Major Target Limb Amputation Rate	through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months	Major Target Limb Amputation rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Clinically-driven Target Lesion Revascularization (CD-TLR) Rate	through 3, 6, 9, 12, 24, 36, 48 and 60 months	Clinically-driven Target Lesion Revascularization (CD-TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Mechanically-driven Target Lesion Revascularization (TLR) Rate	through 37 days	Mechanically-driven Target Lesion Revascularization (TLR) rate
Target Lesion Revascularization (TLR) Rate	through 3, 6, 9, 12, 24, 36, 48 and 60 months	Target Lesion Revascularization (TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Clinically-driven Target Vessel Revascularization (CD-TVR) Rate	through 3, 6, 9, 12, 24, 36, 48 and 60 months	Clinically-driven Target Vessel Revascularization (CD-TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Target Vessel Revascularization (TVR) Rate	through 3, 6, 9, 12, 24, 36, 48 and 60 months	Target Vessel Revascularization (TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Status of Wound Healing	at 30 days, 3, 6, 9, 12, 24 and 36 months	Status of wound healing for baseline wounds: completely healed - improvement - unchanged - worsened - Amputation - skin graft; percentage of wounds in each category is presented for each treatment arm
Rate of Thrombosis at the Target Lesion	through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months	Rate of thrombosis at the target lesion, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Device Success	at the time of procedure	Calculated as the number of IN.PACT 014 Investigational devices with successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP), divided by the total number of IN.PACT 014 Investigational devices assessed in the study
Clinical Success	up to discharge visit [between index procedure and 30-day (+/- 7 days) follow-up visit. The average days until discharge was: 9 days (with a max. of 31days) in the IN.PACT 014 arm, and 6 days (with a max. of 21days) in the PTA arm.]	Clinical success is defined as residual stenosis of ≤ 30% without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)). If any lesion has residual stenosis \> 30% or any of the complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge, then subject is not counted as having Clinical Success.; Clinical success is calculated as the number of index procedures with residual stenosis of ≤ 30% by core lab (use site reported data if core lab data is not available) for all target lesions and without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge as adjudicated by CEC, divided by the number of total index procedures performed.

Trial Locations

Locations (9)

AZ Sint Blasius; 🇧🇪 Dendermonde, East-Flanders, Belgium

ZOL Genk; 🇧🇪 Genk, Limburg, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Hopital Guillaume et Rene Laennec - Centre Hospitalier Universitaire; 🇫🇷 Nantes, France

University Hospital Patras; 🇬🇷 Patras, Greece

IRCCS Multimedica; 🇮🇹 Sesto San Giovanni, Lombardy, Italy

Maria Cecilia Hospital; 🇮🇹 Cotignola, Ravenna, Italy

Ospedale San Donato; 🇮🇹 Arezzo, Italy

University Hospital Zurich; 🇨🇭 Zürich, Switzerland