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Critical Limb IschemiaNCT02963649

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

A study testing DCB and PTA in people with Critical Limb Ischemia and Peripheral Arterial Disease, run by Medtronic Endovascular at 9 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DCB and PTA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
9 sitesin 5 countries
Study dates
2 Mar 2017to 21 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Subjects with neutrotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk of major amputation.
  • Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement.
  • Impaired renal function (GFR <20 mL/min) and patients on dialysis.
  • Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment.
  • Patient receiving systemic corticosteroid therapy.
  • 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.
  • The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.
  • Female subjects who are breastfeeding at the time of enrollment.

Trial locations and contacts

9 sites in 5 countries.

9 sites in 5 countries

Belgium3 sites

  • AZ Sint Blasius

    Dendermonde, East-Flanders, 9200

  • ZOL Genk

    Genk, Limburg, 3600

  • Universitair Ziekenhuis Gent

    Ghent, 9000

Other trials in Belgium

Italy3 sites

  • Ospedale San Donato

    Arezzo, 50200

  • Maria Cecilia Hospital

    Cotignola, Ravenna, 48033

  • IRCCS Multimedica

    Sesto San Giovanni, Lombardy, 20099

Other trials in Italy

France1 site

  • Hopital Guillaume et Rene Laennec - Centre Hospitalier Universitaire

    Nantes

Other trials in France

Greece1 site

  • University Hospital Patras

    Pátrai

Other trials in Greece

Switzerland1 site

  • University Hospital Zurich

    Zurich

Other trials in Switzerland

About this study

Official title: 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

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.

Being tested
DCB, PTA
Medical subject headings
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DCBDevice

    Drug Coated Balloon

  • PTADevice

    Percutaneous Transluminal Angioplasty

Study groups in NCT02963649
Study groupRoleWhat they receive
Drug Coated Balloon IN.PACT 014 (DCB)ExperimentalParticipants who receive IN.PACT 014.
Receives: Device: DCB
Percutaneous Transluminal Angioplasty (PTA)Active comparatorParticipants who receive standard PTA treatment.
Receives: Device: PTA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 9 Months

Secondary outcomes (14)

  1. 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 target lesion revascularization (CD-TLR) within 9 months post-index procedure

    Measured: 9 Months

  2. Major Adverse Event (MAE) Rate

    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

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

  3. Functional Flow Assessment

    is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound.

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

  4. Death of Any Cause

    Death of any cause, reported by using the event-free survival Kaplan-Meier estimate through 60 months

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

  5. Major Target Limb Amputation Rate

    Major Target Limb Amputation rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

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

  6. Clinically-driven Target Lesion Revascularization (CD-TLR) Rate

    Clinically-driven Target Lesion Revascularization (CD-TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

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

  7. Mechanically-driven Target Lesion Revascularization (TLR) Rate

    Mechanically-driven Target Lesion Revascularization (TLR) rate

    Measured: through 37 days

  8. Target Lesion Revascularization (TLR) Rate

    Target Lesion Revascularization (TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

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

  9. Clinically-driven Target Vessel Revascularization (CD-TVR) Rate

    Clinically-driven Target Vessel Revascularization (CD-TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

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

  10. Target Vessel Revascularization (TVR) Rate

    Target Vessel Revascularization (TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

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

  11. Status of Wound Healing

    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

    Measured: at 30 days, 3, 6, 9, 12, 24 and 36 months

  12. Rate of Thrombosis at the Target Lesion

    Rate of thrombosis at the target lesion, reported by using the event-free survival Kaplan-Meier estimate through 60 months

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

  13. Device Success

    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

    Measured: at the time of procedure

  14. Clinical Success

    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.

    Measured: 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.]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2016 (estimated)
  2. Study start2 Mar 2017
  3. Primary completion7 Oct 2019
  4. Study completion21 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02963649
Sponsor's protocol ID
APV-IN.PACT BTK OUS
Status last verified
Jul 2025
First submitted
9 Nov 2016
Last updated
8 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34602386

Questions about this trial

What is this clinical trial studying?

A study testing DCB and PTA in people with Critical Limb Ischemia and Peripheral Arterial Disease, run by Medtronic Endovascular at 9 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Belgium, Italy, France, Greece, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months (time frame: 9 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02963649, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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