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

NCT02963649 | Completed Results DMC

• 1 other identifier: APV-IN.PACT BTK OUS
• Study Type: interventional
• Target: 50
• Locations: 5 countries
• Sites: 9

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.

Conditions

Critical Limb Ischemia; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 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

  9 Months

Secondary Outcomes (14)

• Composite Safety Endpoint

  9 Months

• Major Adverse Event (MAE) Rate

  through 3, 6, 9, 12, 24, 36, 48 and 60 months

• Functional Flow Assessment

  at 3, 6, 9, 12, 24 and 36 months

• Death of Any Cause

  through 3, 6, 9, 12, 24, 36, 48 and 60 months

• Major Target Limb Amputation Rate

  through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months

Study Arms (2)

Drug Coated Balloon IN.PACT 014 (DCB)

EXPERIMENTAL

Participants who receive IN.PACT 014.

Device: DCB

Percutaneous Transluminal Angioplasty (PTA)

ACTIVE COMPARATOR

Participants who receive standard PTA treatment.

Device: PTA

Interventions

DCB DEVICE

Drug Coated Balloon

Drug Coated Balloon IN.PACT 014 (DCB)

PTA DEVICE

Percutaneous Transluminal Angioplasty

Percutaneous Transluminal Angioplasty (PTA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Subject has been informed of the nature of the study, agrees to participate and has signed an EC approved consent form.
• 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.
• Subject has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Clinical Category 4 or 5.
• Subjects with documented infection grade 0-2 and ischemia grade 2-3 according to WIfi classification.
• Life expectancy \>1 year in the Investigator's opinion.
• Reference Vessel Diameter (RVD) 2 - 4 mm, and confirmed by DUS assessment.
• Total occlusions with total lesion length ≥ 40 mm (by visual estimate).
• Lesion must be located in the infrapopliteal arteries and above the ankle joint.
• Multiple lesions can be treated if located in separate vessels.
• Presence of documented run-off to the foot.
• Inflow free from flow-limiting lesion confirmed by angiography.
• Successful pre-dilatation of the (entire) target lesion.

You may not qualify if:

• Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study.
• Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre or post-procedure.
• Lesion and/or occlusions located or extending in the popliteal artery or below the ankle joint space.
• Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries left untreated.
• Failure to obtain ≤ 30% residual stenosis in pre-existing, hemodynamically significant inflow lesions in the ipsilateral iliac, SFA and popliteal artery.
• Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization.
• Previous DCB procedure in the target vessel within 6 months prior to index procedure.
• Aneurysm in the target vessel.
• Angiographic evidence of thrombus within target limb.
• Pre-dilatation resulted in major (≥ Grade D) flow-limiting dissection or residual stenosis \> 30%.
• Use of alternative therapy e.g. atherectomy, cutting balloon, laser, radiation therapy, stents as part of target vessel treatment.
• Recent MI or stroke \< 30 days prior to the index procedure.
• Heart failure with Ejection Fraction \< 30%.
• Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound on the target limb.
• Subjects with infection grade 3 and ischemia grade 0 and 1 according to the Wifi classification.

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (9)

AZ Sint Blasius

Dendermonde, East-Flanders, 9200, Belgium

Location

ZOL Genk

Genk, Limburg, 3600, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Hopital Guillaume et Rene Laennec - Centre Hospitalier Universitaire

Nantes, France

Location

University Hospital Patras

Pátrai, Greece

Location

IRCCS Multimedica

Sesto San Giovanni, Lombardy, 20099, Italy

Location

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

Location

Ospedale San Donato

Arezzo, 50200, Italy

Location

University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34602386 DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Results Point of Contact

• Title: Giulia Gatta, Clinical Study Manager
• Organization: Medtronic

giulia.gatta@medtronic.com

+310629467793

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 15, 2016
• Study Start: March 2, 2017
• Primary Completion: October 7, 2019
• Study Completion: December 21, 2023
• Last Updated: July 8, 2025
• Results First Posted: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); GR (1); BE (3); IT (3); FR (1)