Infrainguinal CTO Recanalization Assessed by Intravascular Ultrasound: Results of the CENTRAL Study
James Torey1, Anwar Zaitoun, Thomas Lalonde
1St. John Hospital and Medical Center, 22101 Moross Road, Detroit, MI 48236 USA. toreyj01@yahoo.com.
Insights
A new recanalization catheter system successfully crossed over half of superficial femoral artery chronic total occlusions (CTOs) in the central lumen. This approach reduced vessel damage and significantly lowered 6-month target-lesion revascularization rates.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Chronic total occlusions (CTOs) in the superficial femoral artery (SFA) present a significant challenge in peripheral artery disease treatment.
- Current recanalization techniques have limitations in achieving consistently safe and effective intraluminal crossing.
Purpose of the Study:
- To evaluate the efficacy and safety of a novel recanalization catheter system for crossing SFA CTOs.
- To assess the impact of successful intraluminal crossing on subsequent target-lesion revascularization (TLR).
Main Methods:
- A prospective, multicenter study involving 100 patients with SFA CTOs.
- Primary endpoint: successful crossing of CTO (≥90% length) within the central lumen, confirmed by intravascular ultrasound.
- Secondary endpoints: assessment of anatomic damage (TAPE method) and correlation with 30-day and 6-month TLR rates.
Main Results:
- Successful central lumen crossing (≥90%) was achieved in 50.6% of cases; >50% luminal crossing in 75.3%.
- Mean occlusion age was 16.6 months, average length 132.1 mm, with significant calcification in most lesions.
- Lower 6-month TLR rates were observed with successful ≥90% central lumen crossing (4.7% vs. 20.6%) and favorable TAPE scores (3.5% vs. 36.8%).
Conclusions:
- The recanalization catheter system demonstrated feasibility in crossing complex SFA CTOs intraluminally in over half of cases.
- Achieving intraluminal crossing and minimizing anatomic damage correlated with significantly improved 6-month TLR rates.
- This technology may offer a significant advantage in managing SFA CTOs, potentially improving long-term outcomes.
Objectives:
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.
Methods:
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.
Results:
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 <90% (20.6%; P=.04). The 6-month TLR rate was 3.5% in patients with a favorable TAPE score of 0-4 and 36.8% with an unfavorable TAPE score of 5-8 (P<.001).
Conclusion:
Use of a recanalization catheter in complex superficial femoral artery CTO crossings achieved intraluminal crossings in >50% of cases and decreased anatomic damage, which appeared to offer a significant advantage in 6-month TLR rates.
