CALCIUM 360º


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

Patient Population

DemographicsOAS + PTA
N = 25
PTA Alone
N = 25
p-value
Mean Age70.7 ± 13.471.8 ± 10.90.75
Male/Female68%/32%60%/40%0.77
Diabetic Type 14%0%1.00
Diabetic Type 268%56%0.56
Renal Insufficiency (GFR <90)25%24%1.00
Smoker (current or previous)60%60%1.00
CAD44%56%0.57
Hypertension84%84%1.00
Dyslipidemia83%72%0.50

Study Results

Calcium 360 - Mean Maximum Balloon Inflation Pressure | amCharts
Calcium 360 - Bail-out Stenting | amCharts

 

 

Calcium 360 - Freedom From Revascularization | amCharts
Calcium 360 - Freedom From Major Adverse Events | amCharts

MAE (major adverse events: device- or procedure-related major amputation (above the ankle), all-cause mortality and TLR/TVR).

Shammas NW, et al. Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther. 2012;19(4):480-8.


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