Clinical Trial: Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study

Brief Summary: The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK) lesions.

Detailed Summary:
Sponsor: Cardiovascular Systems Inc

Current Primary Outcome:

  • Technical success (per lesion), defined as final residual stenosis post DCB angioplasty < 50 % via angiography without significant angiographic complications [ Time Frame: Index Procedure ]
    Technical success (per lesion), defined as final residual stenosis post DCB angioplasty < 50 % via angiography without significant angiographic complications (perforation, distal embolization, dissection types C-F, slow flow/no reflow) during the index procedure
  • Procedural success (per subject), defined as achievement of technical success for all target lesions treated [ Time Frame: Index Procedure ]
    Procedural success (per subject), defined as achievement of technical success for all target lesions treated during the index procedure
  • Device success (per each DCB used during the index procedure), defined as the ability to achieve successful delivery and deployment of the DCB to the target lesion as described per Instructions for Use (IFU) [ Time Frame: Index Procedure ]
    Device success (per each DCB used during the index procedure), defined as the ability to achieve successful delivery and deployment of the DCB to the target lesion as described per Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device
  • Treatment success (per lesion), defined as the percentage of target lesions meeting technical success with < 30 % final residual stenosis post DCB angioplasty [ Time Frame: Index Procedure ]
    Treatment success (per lesion), defined as the percentage of target lesions meeting technical

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Late Lumen Loss (LLL) of the target lesion by Quantitative Vascular Angiography (QVA) [ Time Frame: 6 Month ]
      Late Lumen Loss (LLL) of the target lesion by Quantitative Vascular Angiography (QVA) at 6 months post-procedure or at the time of Target Lesion Revascularization (TLR)
    • Patency of the target lesion by Duplex Ultrasound (DUS) post-procedure [ Time Frame: 6 Month and 12 Month ]
      Patency of the target lesion by Duplex Ultrasound (DUS) at 6 months and 12 months post-procedure
    • Freedom from Major Adverse Events (MAEs) post-procedure [ Time Frame: 30 Day, 3 Month, 6 Month, 12 Month, 24 Month ]
      Freedom from Major Adverse Events (MAEs) at 30 days, 3 months, 6 months, 12 months, and 24 months post-procedure. MAEs include: clinically driven TLR; unplanned, unavoidable major amputation of the index limb; and death within 30 days of the index procedure.
    • Freedom from clinically driven target lesion revascularization [ Time Frame: 30 Day, 3 Month, 6 Month, 12 Month, 24 Month ]
      Freedom from clinically driven target lesion revascularization at 30 days, 3 months, 6 months, 12 months, and 24 months post-procedure
    • Freedom from unplanned, unavoidable major amputation of the index limb [ Time Frame: 30 Day, 3 Month, 6 Month, 12 Month, 24 Month ]
      Freedom from unplanned, unavoidable major amputation of the index limb at 30 days, 3 months, 6 months, 12 months, and 24 months post-procedure
    • Change in Rutherford Category [ Time Frame: 30 Day, 3 Month, 6 Month, 12 Month, 24 Month ]
      Change in Rutherford Category at 30 days, 3 months, 6 months, 12 months, and 24 months post-procedure from baseline
    • Hemodynamic outcome (Ankle-Brachial Index and Toe-Brachial Index) [ Time Frame: 3 Month, 6 Month, 12 Month ]
      Hemodynamic outcome (ABI and TBI) at 3 months, 6 months, and 12 months post-procedure compared to baseline
    • Change in quality of life (QoL) [ Time Frame: 30 Day, 3 Month, 6 Month, 12 Month, 24 Month ]
      Change in quality of life (QoL) at 30 days, 3 months, 6 months, 12 months, and 24 months post-procedure from baseline assessed by EuroQoL Quality of Life Questionnaire (EQ-5D)
    • Change in walking capacity [ Time Frame: 30 Day, 3 Month, 6 Month, 12 Month, 24 Month ]
      Change in walking capacity at 30 days, 3 months, 6 months, 12 months, and 24 months post-procedure from baseline assessed by Walking Impairment Questionnaire (WIQ)
    • Quality of life using the EQ-5D-5L questionnaire [ Time Frame: 30 Day, 3 Month, 6 Month, 12 Month, 24 Month ]
      EQ-5D summary scores (min value 0, max value 1), in conjunction with mortality data, will be used to compute quality adjusted life years (QALY) for further health-economic analyses. The QALY results will be compared between treatment arms at various time points during follow-up at 30 days, 3 months, 6 months, 12 months, and 24 months
    • Treatment-related costs [ Time Frame: Index Procedure, 30 Day, 3 Month, 6 Month, 12 Month, 24 Month ]
      Inpatient cost and reimbursement data will be obtained from participating hospitals, and compared between treatment arms at various time points during follow-up.


    Original Secondary Outcome: Same as current

    Information By: Cardiovascular Systems Inc

    Dates:
    Date Received: August 26, 2015
    Date Started: September 2015
    Date Completion: June 2018
    Last Updated: June 7, 2016
    Last Verified: June 2016