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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02963649
Recruitment Status : Active, not recruiting
First Posted : November 15, 2016
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

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

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Peripheral Arterial Disease Device: DCB Device: PTA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Study of IN.PACT 014 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter vs. Standard Percutaneous Transluminal Angioplasty for the Treatment of Chronic Total Occlusions in the Infrapopliteal Arteries
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : October 7, 2019
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: drug-eluting balloon IN.PACT 014
product is indicated for PTA in patients with obstructive disease of peripheral arteries with paclitaxel drug - elution.
Device: DCB
Drug Coated Balloon

Active Comparator: Standard angioplasty balloon
standard PTA balloon
Device: PTA
Percutaneous Transluminal Angioplasty




Primary Outcome Measures :
  1. Efficacy: Late lumen loss (LLL) at 9 months [ Time Frame: 9 Months ]
    Late lumen loss (LLL) at 9 months


Secondary Outcome Measures :
  1. Composite Safety Endpoint [ Time Frame: 30 days and 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.

  2. Major Adverse Event (MAE) rate [ Time Frame: 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)

  3. Status of wound healing [ Time Frame: at 30 days, 3, 6, 9, 12, 24 and 36 months ]
    completely healed - improvement - unchanged - worsened

  4. Rate of thrombosis at the target lesion [ Time Frame: through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months ]
    Rate of thrombosis at the target lesion

  5. Device success [ Time Frame: at the time of procedure ]
    is defined as successful drug delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).

  6. Clinical success [ Time Frame: up to discharge visit ]
    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))

  7. Functional flow assessment [ Time Frame: at 3, 6, 9, 12, 24 and 36 months ]
    is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound

  8. Death of any cause and cardiovascular-related deaths [ Time Frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months ]
    Death of any cause and cardiovascular-related deaths

  9. Major Target Limb Amputation rate [ Time Frame: through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months ]
    Major Target Limb Amputation rate

  10. Mechanically-driven Target Lesion Revascularization (TLR) rate [ Time Frame: through 37 days ]
    Mechanically-driven Target Lesion Revascularization (TLR) rate

  11. Target Lesion Revascularization (TLR) rate [ Time Frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months ]
    Target Lesion Revascularization (TLR) rate

  12. Clinically-driven Target Lesion Revascularization (CD-TLR) rate [ Time Frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months ]
    Clinically-driven Target Lesion Revascularization (CD-TLR) rate

  13. Target Vessel Revascularization (TVR) rate [ Time Frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months ]
    Target Vessel Revascularization (TVR) rate

  14. Clinically-driven Target Vessel Revascularization (CD-TVR) rate [ Time Frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months ]
    Clinically-driven Target Vessel Revascularization (CD-TVR) rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963649


Locations
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Belgium
AZ Sint Blasius
Dendermonde, East-Flanders, Belgium, 9200
ZOL Genk
Genk, Limburg, Belgium, 3600
Regionaal Ziekenhuis Heilig Hart
Tienen, Vlaams Brabant, Belgium, 3300
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
France
Hopital Guillaume et Rene Laennec - Centre Hospitalier Universitaire
Nantes, France
Greece
University Hospital Patras
Patras, Greece
Italy
IRCCS Multimedica
Sesto San Giovanni, Lombardy, Italy, 20099
Maria Cecilia Hospital
Cotignola, Ravenna, Italy, 48033
Ospedale San Donato
Arezzo, Italy, 50200
Switzerland
University Hospital Zurich
Zürich, Switzerland
Sponsors and Collaborators
Medtronic Endovascular
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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT02963649    
Other Study ID Numbers: APV-IN.PACT BTK OUS
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medtronic Endovascular:
Drug-eluting angioplasty balloon, Drug coated angioplasty balloon, Experimental, percutaneous transluminal angioplasty (PTA)
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases