OPTIMIZE - Follow-Up Phase | CSI360

OPTIMIZE – Follow-Up Phase


OPTIMIZE is a prospective, randomized one to one (1:1), multi-center European pilot study designed to evaluate Orbital Atherectomy vessel preparation prior to drug coated balloons (DCBs) compared to DCB alone for the treatment of calcified below-the-knee lesions.

Study Design

  • Approximately 50 patients will be enrolled at up to 10 European sites and followed for up to 2 years
  • Late lumen loss at 6 months post-procedure will be an outcome measure

Other Studies

  • Liberty360
    LIBERTY 360º
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    Click HERE TO SEE THE LIBERTY 360° Study 3-Year Data LIBERTY is the largest, contemporary, real-world experience study to evaluate procedural and long-term clinical outcomes of endovascular device interventions in patients with symptomatic lower extremity peripheral artery disease (PAD). Study Design1   Prospective, observational, multicenter study that includes any FDA-cleared or approved technology to treat claudication and critical limb ischemia (CLI). 1204 patients enrolled at 51 sites and were followed for up to 5 years. 4 core labs used for independent analysis. Key endpoints: Procedural and lesion success, Major Adverse Events (MAEs), Duplex Ultrasound (DUS), Quality of Life (QoL), and Six-Minute Walk Test (6MWT). Key inclusion criteria: Rutherford classification (RC) 2 to 6, target lesion located within or extending into 10 cm above the medial epicondyle to the digital arteries (distal 1/3 of the SFA and below), and at least one lesion that can be treated with an endovascular device.   Conclusion Peripheral vascular intervention (PVI) may be a reasonable treatment option across all Rutherford classes with durable results lasting to 3-years.2 High freedom from major amputation TVR/TLR at 3 years across all Rutherford classes2 In the OAS sub-analysis, freedom from major amputation TVR/TLV rates at 3 years were even higher than in the full patient cohort2 Improved Quality of Life by 30 days and maintained to 3 years across all Rutherford classes High long-term patency rates through 2 years in RC2-33 Improvement in mean number of wounds from 30 days to 2 years in RC4-63   1. Mustapha et al. One-Year Results of the LIBERTY 360 Study. J Endovasc Ther. 2019;26(2):143-154. 2. Mustapha JA. LIBERTY 360 Trial 3-Year Update. Presented at AMP 2019. 3. Mustapha JA. Late Breaking: LIBERTY 360 Trial 2-Year Update. Presented at AMP 2018.
  • CALCIUM-360
    CALCIUM 360º
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    A prospective, randomized, multi-center study that compared the acute and long-term results of Orbital Atherectomy System (OAS) + percutaneous transluminal angioplasty (PTA) versus PTA alone in calcified below-the-knee (BTK) lesions. Key Takeaways Lower mean maximum balloon inflation pressure in OAS+PTA arm Lower rate of major adverse events at 12-months in OAS+PTA arm Study Design 50 Critical Limb Ischemia (CLI) patients enrolled at 8 U.S. sites Patients randomized to either OAS+PTA (25 pts) or PTA alone (25 pts) and followed for 12 months
  • Truth Clinical Study
    TRUTH
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    A prospective, single-arm, single-center study using intravascular ultrasound (IVUS) to assess Orbital Atherectomy System (OAS)-related plaque modification of femoropopliteal lesions. Key-Takeaways OAS modified the calcified component of the plaque burden (IVUS analysis) Calcium reduction was responsible for 86% of lumen area increase (IVUS analysis) Increase in minimum lumen area post-OAS (IVUS analysis) Low mean maximum balloon inflation pressure post-OAS of 5.2 atm Study Design 25 patients enrolled at a single center Patients treated with OAS+ percutaneous transluminal angioplasty (PTA) and followed for 12 months IVUS images collected pre-OAS, post-OAS, and post-PTA (IVUS Core Lab)
  • Compliance360
    COMPLIANCE 360º
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    A prospective, randomized, multi-center study that compared the acute and long-term results of Orbital Atherectomy System (OAS) + percutaneous transluminal angioplasty (PTA) versus PTA alone in calcified above-the-knee (ATK) lesions. Key Takeaways Lower mean maximum balloon inflation pressure in OAS+PTA arm Lower adjunctive stent rate in OAS+PTA arm OAS demonstrated reduced stenting with durable results out to 12 months versus PTA alone Study Design 50 patients enrolled at 9 U.S. sites Patients randomized to either OAS+PTA (25 pts) or PTA alone (25 pts) and followed for 12 months
  • OPTIMIZE - Follow-Up Phase
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    OPTIMIZE is a prospective, randomized one to one (1:1), multi-center European pilot study designed to evaluate Orbital Atherectomy vessel preparation prior to drug coated balloons (DCBs) compared to DCB alone for the treatment of calcified below-the-knee lesions. Study Design Approximately 50 patients will be enrolled at up to 10 European sites and followed for up to 2 years Late lumen loss at 6 months post-procedure will be an outcome measure
  • REACH PVI
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    REACH PVI is a prospective, observational, single-arm, multi-center, post-market clinical study designed to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions. Study Design Approximately 50 subjects will be enrolled at up to ten (10) active sites in the United States (U.S.) The primary outcome is defined as successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access related events Subjects will be followed post-procedure through the first standard of care follow-up visit (7-45 days post procedure)