Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval.

IF 2.9 3区医学 Q3 ENGINEERING, BIOMEDICAL Expert Review of Medical Devices Pub Date : 2023-07-01 DOI:10.1080/17434440.2023.2214679

Elias Noory, Gunnar Tepe, Michael Piorkowski, Marcus Thieme, Stefan Müller-Hülsbeck, Klaus Brechtel, Michael Lichtenberg, Ulrich Beschorner, Tanja Böhme, Thomas Zeller

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Abstract

Objectives: Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval.

Methods: Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (outer layer) composite balloon. The ePTFE layer is coated with paclitaxel (concentration: 3.5 μg/mm²) and the excipient stearic acid/tromethamine (tris). The primary endpoints were 6-month late lumen loss (LLL) and 30-day of freedom from Major Adverse Events (MAE).

Results: Fifty-two subjects were enrolled, 69% men, median age 69 (49-83) years. Acute device success was 100%, the 30-day MAE rate was zero. Study primary endpoint of LLL (-0.17 mm) showed significant superiority compared to the performance goal of uncoated PTA balloon catheters from literature. At 1 and 2 years, primary patency rates were 81.8% and 68.7%, respectively, and freedom from clinically driven target lesion revascularization rates was 87.9% and 83.4%, respectively.

Conclusion: The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective.

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GORE药物包被PTA球囊导管用于CE认证的临床研究。

目的:紫杉醇包被球囊血管成形术已被确立为股腘动脉疾病的一线治疗方法。该研究的主要目的是评估GORE-DCB导管治疗外周动脉疾病患者股腘动脉粥样硬化病变的性能和安全性，以获得CE-Mark批准。方法:前瞻性、单臂、多中心研究，随访24个月。GORE-DCB导管由药物涂层尼龙(内层)/ePTFE(外层)复合球囊组成。ePTFE层包被紫杉醇(浓度:3.5 μg/mm2)和赋形剂硬脂酸/三甲基胺(tris)。主要终点是6个月晚期管腔损失(LLL)和30天无主要不良事件(MAE)。结果:52名受试者入组，69%为男性，中位年龄69(49-83)岁。急性装置成功率为100%，30天MAE率为零。研究的主要终点LLL (-0.17 mm)与文献中未涂覆PTA球囊导管的性能目标相比具有显著优势。在1年和2年，原发性通畅率分别为81.8%和68.7%，免于临床驱动的靶病变血运重建率分别为87.9%和83.4%。结论:GORE-DCB导管治疗股腘动脉病变安全有效。

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来源期刊

Expert Review of Medical Devices 医学-工程：生物医学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： The journal serves the device research community by providing a comprehensive body of high-quality information from leading experts, all subject to rigorous peer review. The Expert Review format is specially structured to optimize the value of the information to reader. Comprehensive coverage by each author in a key area of research or clinical practice is augmented by the following sections: Expert commentary - a personal view on the most effective or promising strategies Five-year view - a clear perspective of future prospects within a realistic timescale Key issues - an executive summary cutting to the author''s most critical points In addition to the Review program, each issue also features Medical Device Profiles - objective assessments of specific devices in development or clinical use to help inform clinical practice. There are also Perspectives - overviews highlighting areas of current debate and controversy, together with reports from the conference scene and invited Editorials.