Infrainguinal CTO Recanalization Assessed by Intravascular Ultrasound: Results of the CENTRAL Study

• Published in: The Journal of invasive cardiology 2016-11, Vol.28 (11), p.430-439
• Main Authors: Torey, James, Zaitoun, Anwar, Lalonde, Thomas, Runyon, John, Mustapha, Jihad, Davis, Thomas
• Format: Article
• Language: English
• Subjects: Aged; Arterial Occlusive Diseases - diagnosis; Arterial Occlusive Diseases - etiology; Arterial Occlusive Diseases - surgery; Catheterization, Peripheral - instrumentation; Catheterization, Peripheral - methods; Female; Femoral Artery - diagnostic imaging; Femoral Artery - pathology; Femoral Artery - surgery; Humans; Ischemia - diagnosis; Ischemia - etiology; Ischemia - surgery; Lower Extremity - blood supply; Male; Middle Aged; Outcome and Process Assessment (Health Care); Peripheral Vascular Diseases - complications; Severity of Illness Index; Ultrasonography, Interventional - methods; Vascular Calcification
• ISSN: 1557-2501

CENTRAL was a prospective, multicenter, 100 patient study designed to evaluate the ability of a recanalization catheter system to cross chronic total occlusions (CTOs) of the superficial femoral artery while staying within the central vessel lumen. The primary endpoint was the successful crossing of a CTO (≥90% of the length) with the recanalization catheter in the central lumen of the superficial femoral artery in at least one-half of the studied patient population, confirmed by intravascular ultrasound. Secondary endpoints included standardized anatomic damage assessment (the TAPE method) and an assessment of the relationship between the percent of CTO crossing and TAPE scores to the rate of target-lesion revascularization (TLR) at 30 days and 6 months. The mean age of the occlusions was 16.6 ± 22.28 months (range, 1-120 months), the average occlusion length reported by the sites was 132.1 ± 87.69 mm (range, 4-300 mm), and a majority of lesions were moderately (42.0%) or severely (32.0%) calcified. In 43/85 (50.6%) of the evaluable intravascular ultrasound images, the recanalization catheter successfully navigated the central lumen of the CTO (ie, ≥90% luminal crossing) with >50% luminal crossing in 64/85 (75.3%) of cases. The 6-month TLR rate was significantly lower in patients where the CTO was crossed ≥90% in the central vessel lumen (4.7%) compared with crossings