Related Experiment Video
Updated: Jul 27, 2026
Microsurgical Creation of Giant Bifurcation Aneurysms in Rabbits for the Evaluation of Endovascular Devices
Published on: September 8, 2023
Large Diameter Advanta V12 Covered Stent Trial for Coarctation of the Aorta: COARC Study
Elchanan Bruckheimer1, Einat Birk1, Lee Benson2
1Schneider Children's Medical Center of Israel, Petach Tikva, Israel (E. Bruckheimer, E. Birk).
Insights
The Large Diameter Advanta V12 covered stent effectively treats coarctation of the aorta (CoA), showing sustained pressure gradient reduction over five years. This study confirms its safety and efficacy for native and recurrent CoA.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Coarctation of the aorta (CoA) treatment often involves stent implantation.
- Long-term outcome data from prospective studies on covered stents for CoA are limited.
- The Large Diameter Advanta V12 covered stent is evaluated for native and recurrent CoA.
Purpose of the Study:
- To assess the acute and long-term outcomes of Large Diameter Advanta V12 covered stent implantation for coarctation of the aorta.
- To evaluate the safety and efficacy of this stent in reducing pressure gradients and maintaining vessel patency.
- To provide long-term imaging and clinical follow-up data for this specific stent in CoA treatment.
Main Methods:
- A prospective, multicenter, nonrandomized study involving 70 patients with CoA.
- Implantation of the Large Diameter Advanta V12 covered stent.
- Annual follow-up for 5 years, including Doppler echocardiography and 12-month computed tomography angiography.
Main Results:
- Significant reduction in pressure gradient (35.8 to 5.6 mm Hg) and increase in CoA diameter (5.6 to 14.9 mm) (P<0.0001).
- Sustained reduction in diastolic:systolic velocity ratio (0.6 to 0.34) over 5 years (P<0.0001).
- Low rates of major adverse vascular events (1.4% at 30 days, 4.3% at 12 months); no mortality.
Conclusions:
- The Large Diameter Advanta V12 covered stent is safe and effective for treating coarctation of the aorta.
- Immediate and sustained pressure gradient reduction is achieved and maintained over 5 years.
- The stent demonstrates favorable long-term outcomes as assessed by imaging and clinical follow-up.
Background:
Covered stent implantation for treatment of coarctation of the aorta (CoA) is effective and can prevent aortic wall injury. Prospective studies with long-term follow-up, including imaging, are lacking. We report the acute and long-term outcomes for use of the Large Diameter Advanta V12 covered stent for treatment of native and recurrent CoA.
Methods:
A prospective, multicenter, nonrandomized study was performed including 70 patients (43 male), median age 17 years, median weight 57.4 kg with CoA who underwent implantation of the Large Diameter Advanta V12 covered stent. Annual follow-up for 5 years included Doppler echocardiography to calculate diastolic velocity: systolic velocity ratio.
Results:
CoA diameter increased from 5.6±3.6 to 14.9±3.9 mm (P<0.0001) and the pressure gradient decreased from 35.8±16.2 to 5.6±7.9 mm Hg (P<0.0001). Preimplantation diastolic velocity:systolic velocity of 0.6±0.16 dropped to 0.34±0.13 (P<0.0001) and was maintained at 5 years. Computed tomography angiograms at 12 months postimplantation demonstrated the stent:transverse arch diameter to be similar, 0.91±0.09 to postprocedure 0.86±0.14. Major adverse vascular events at 30 days and 12 months were 1.4% and 4.3%, respectively. Significant adverse events included three patients who required stent implantation to treat infolding. There were no mortalities.
Conclusions:
The Large Diameter Advanta V12 covered stent is safe and effective for the treatment of CoA with an immediate and sustained reduction of the pressure gradient over 12 months and 5 years as assessed by preimplantation and postimplantation Doppler echocardiography and 12-month computed tomography angiography. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00978952. URL: http://www.anzctr.org.au; Unique identifier: ACTRN12612000013864.
