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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The ePTFE layer is coated with paclitaxel (concentration: 3.5 μg/mm<sup>2</sup>) 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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective.</p>","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 7","pages":"575-588"},"PeriodicalIF":2.9000,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval.\",\"authors\":\"Elias Noory, Gunnar Tepe, Michael Piorkowski, Marcus Thieme, Stefan Müller-Hülsbeck, Klaus Brechtel, Michael Lichtenberg, Ulrich Beschorner, Tanja Böhme, Thomas Zeller\",\"doi\":\"10.1080/17434440.2023.2214679\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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/mm<sup>2</sup>) 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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective.</p>\",\"PeriodicalId\":12330,\"journal\":{\"name\":\"Expert Review of Medical Devices\",\"volume\":\"20 7\",\"pages\":\"575-588\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2023-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert Review of Medical Devices\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://doi.org/10.1080/17434440.2023.2214679\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ENGINEERING, BIOMEDICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Review of Medical Devices","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1080/17434440.2023.2214679","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ENGINEERING, BIOMEDICAL","Score":null,"Total":0}
Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval.
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.
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.
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