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

This study is currently recruiting participants.
Verified July 2017 by Medtronic Endovascular
Sponsor:
ClinicalTrials.gov Identifier:
NCT02963649
First Posted: November 15, 2016
Last Update Posted: July 12, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Endovascular
  Purpose
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 Intervention
Critical Limb Ischemia Peripheral Arterial Disease Device: DCB Device: PTA

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

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


Secondary Outcome Measures:
  • 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.

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

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

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

  • 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).

  • 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)


Estimated Enrollment: 60
Actual Study Start Date: March 2, 2017
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years and ≤85 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 PTA of the target vessel within 12 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.
  10. Patient receiving systemic corticosteroid therapy.
  11. Inability to tolerate concomitant antiplatelet therapy on top of oral anticoagulation therapy
  12. 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.
  13. The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.
  Contacts and Locations
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
ZOL Genk Recruiting
Genk, Limburg, Belgium, 3600
Contact: Wouter Lansink, MD       wouter.lansink@zol.be   
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Contact: Frank Vermassen, Professor       frank.vermassen@ugent.be   
Principal Investigator: Frank Vermassen         
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   
Sponsors and Collaborators
Medtronic Endovascular
  More Information

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT02963649     History of Changes
Other Study ID Numbers: APV-IN.PACT BTK OUS
First Submitted: November 9, 2016
First Posted: November 15, 2016
Last Update Posted: July 12, 2017
Last Verified: July 2017

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