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TRUTH

Truth Clinical Study

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)

Patient Population

Baseline Characteristicn=25
Age70.4 ± 7.8 years (n=25)
Gender (Male)19/25 (76.0%)
eGFR (mL/min/1.73 m2)70.9 ± 25.0 (n=25)
History of diabetes (Type I or II)18/25 (72.0%)
History of hyperlipidemia25/25 (100.0%)
History of hypertension25/25 (100.0%)
Smoker (current or former)21/25 (84.0%)
Rutherford classification3.0 ± 0.0

 

Study Results

  • The mean maximum balloon inflation pressure was 5.2±1.2 atm.
  • Virtual histology IVUS (VH-IVUS) analysis revealed at the maximum calcium ablation site that calcium reduction was responsible for 86% of the lumen area increase.
  • The minimum lumen area increased from 4.0 mm2 to 9.1 mm2 (P<0.0001).
Baseline
(N=25)		12-Month Follow-up
(N=22)		P-value
Rutherford Classification (RC)<0.001
Asymptomatic (RC 0)0 (0.0%)13 (59.1%)
Mild Claudication (RC 1)0 (0.0%)8 (36.4%)
Moderate Claudication (RC 2)0 (0.0%)1 (4.5%)
Severe Claudication (RC 3)25 (100.0%)0 (0.0%)
ABI*0.74 ± 0.13 (n=22)0.95 ± 0.15 (n=21)<0.001
*Greater of posterior tibial or dorsalis pedis systolic pressure divided by maximum of left or right brachial systolic pressure.

At 12 months, the freedom from target lesion revascularization (FF TLR) rate was 91.8%, and ankle-brachial index and Rutherford classification improved significantly from baseline through follow-up.

 

Babaev A, et al. Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study). Vasc Endovascular Surg. 2015;49(7):188-94.

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