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

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ClinicalTrials.gov Identifier: NCT02963649
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : May 11, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022

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: 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 TLR within 9 months post-index procedure.

  2. Major Adverse Event (MAE) rate [ Time Frame: through 3, 6, 9, 12, 24 and 36 months ]
    Major Adverse Event (MAE) rate

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

  4. Thrombosis at the target lesion [ Time Frame: through 30 days, 3, 6, 9, 12, 24 and 36 months ]
    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 TVR)



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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. Life expectancy >1 year in the Investigator's opinion.
  6. Reference Vessel Diameter (RVD) 2 - 4 mm, based on visual estimation.
  7. Presence of documented run-off to the foot
  8. Inflow free from flow-limiting lesion confirmed by angiography.
  9. 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. Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization.
  3. Previous DCB of the target vessel within 6 months prior to index procedure.
  4. Aneurysm in the target vessel.
  5. Angiographic evidence of thrombus within target limb.
  6. Recent MI or stroke < 30 days prior to the index procedure.
  7. Heart failure with Ejection Fraction < 30%.
  8. Impaired renal function (GFR <30 mL/min) and patients on dialysis.
  9. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment.
  10. Patient receiving systemic corticosteroid therapy.
  11. 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.
  12. The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.

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


Contacts
Contact: Stijn Bollen +31433566792 stijn.bollen@medtronic.com

Locations
Belgium
AZ Sint Blasius Recruiting
Dendermonde, East-Flanders, Belgium, 9200
Contact: Koen Deloose, MD       koen.deloose@azsintblasius.be   
ZOL Genk Recruiting
Genk, Limburg, Belgium, 3600
Contact: Wouter Lansink, MD       wouter.lansink@zol.be   
Regionaal Ziekenhuis Heilig Hart Recruiting
Tienen, Vlaams Brabant, Belgium, 3300
Contact: Koen Keirse, MD       koen.keirse@rztienen.be   
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Contact: Frank Vermassen, Professor       frank.vermassen@ugent.be   
Principal Investigator: Frank Vermassen         
France
Hopital Guillaume et Rene Laennec - Centre Hospitalier Universitaire Recruiting
Nantes, France
Contact: Yann Goueffic, MD       yann.goueffic@chu-nantes.fr   
Greece
University Hospital Patras Recruiting
Patras, Greece
Contact: Konstantinos Katsanos, MD       katsanos@med.upatras.gr   
Italy
IRCCS Multimedica Recruiting
Sesto San Giovanni, Lombardy, Italy, 20099
Contact: Flavio Airoldi, MD       flavio.airoldi@multimedica.it   
Maria Cecilia Hospital Recruiting
Cotignola, Ravenna, Italy, 48033
Contact: Antonio Micari, MD       antoniomicari@tiscali.it   
Principal Investigator: Antonio Micari         
Ospedale San Donato Recruiting
Arezzo, Italy, 50200
Contact: Francesco Liistro, MD       francescoliistro@hotmail.com   
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Netherlands
Contact: Michel Reijnen, MD       MReijnen@rijnstate.nl   
Switzerland
University Hospital Zurich Recruiting
Zürich, Switzerland
Contact: Martin Banyai, MD       martin.banyai@usz.ch   
Sponsors and Collaborators
Medtronic Endovascular

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT02963649     History of Changes
Other Study ID Numbers: APV-IN.PACT BTK OUS
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

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:
Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases