Presenter: Prof. Thomas Zeller

Affiliation: University Heart Center Bad Krozingen, Germany

Abstract

Prospective multicenter study (n=101) demonstrates: COVERA™ PLUS covered stent achieves 3.0% TLR (p=0.0015 vs 12% performance goal) and 84.8% primary patency at 9 months for iliac stenotic/occlusive disease.

Introduction

Iliac artery disease carries high restenosis risk, with bare-metal stents showing >30% reintervention at 5 years. BD's COVERA™ PLUS stent combines nitinol skeleton with ePTFE membrane to inhibit neointimal hyperplasia, offering a novel solution for complex lesions.

Key Findings (Prospective Multicenter Trial)

1.Patient Profile

101 patients (mean age 61.3), 64.4% smokers, 79.2% hypertension

Lesions: 77.5% stenosis (mean 85.8% occlusion), 22.5% total occlusion

TASC Class: 90% A/B (64.5% A + 25.5% B)

64% common iliac, 35.1% external iliac involvement

2.Procedural Excellence

97.2% pre-dilation, 99.1% post-dilation

Mean stent diameter 8.4mm, length 50.8mm

Kissing stents in 6.7%

97.5% technical success, 4.86% residual stenosis

3.9-Month Efficacy

4.Safety Milestones

Zero device-related death/MI/amputation at 30 days

No unanticipated device effects through 9 months

COVERA™ PLUS Advantages

1.Structural Innovation

Dual-layer: Nitinol framework + ePTFE membrane (suppresses hyperplasia)

Carbon coating: Blood-contact surface reduces thrombogenicity

Precise deployment: Tantalum markers at both ends enhance visibility

2.Clinical Versatility

Diameter range: 4.5-10mm

Configurations: Straight (outflow≤inflow) / Flared (outflow>inflow) designs

Delivery: 8-9Fr sheath compatibility minimizes access injury

Conclusions

1.Short-term superiority: 3% TLR sets new benchmark, ideal for TASC A/B lesions

2.Long-term evidence pending: 24/36-month data will validate durability in occlusions

3.Technical imperative: Near-universal post-dilation ensures optimal apposition

Clinical Note: TASC C/D lesions represented <10%, warranting larger cohort validation.