https://orcid.org/0000-0001-6011-9466
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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.
Abbreviations
| ABI | = | ankle brachial index |
| BfArM | = | Bundesamt für Arzneimittel und Medizinprodukte |
| CD | = | clinically-driven |
| CE | = | conformite europeenne (European conformity) |
| CEC | = | clinical event committee |
| CIP | = | clinical investigational plan |
| CRF | = | case report form |
| DCB | = | drug-coated balloon |
| DSMB | = | data safety and monitoring board |
| DUS | = | duplex ultrasound |
| EC | = | ethics committee |
| EQ-5D-3 L | = | European Quality of Life 5 Dimensions 3 Level Instrument |
| ICF | = | informed consent form |
| ITT | = | intention to treat |
| LLL | = | late lumen loss |
| MAE | = | major adverse event |
| MLD | = | minimal lumen diameter |
| PAD | = | peripheral artery disease |
| POBA | = | plain old balloon angioplasty |
| PSVR | = | peak systolic velocity ratio |
| PA | = | popliteal artery |
| PTA | = | percutaneous transluminal angioplasty |
| RVD | = | reference vessel diameter |
| SFA | = | superficial femoral artery |
| TASC | = | transatlantic intersociety consensus |
| TLR | = | target lesion revascularization |
| TVR | = | target vessel revascularization |
Declaration of interest
EN: Honoraria received from BARD-BD, Boston Scientific, Abbott, Medtronic, ShockWave, Cordis
GT: No conflict of interest
MP: Honoraria, Institutional Grants for research, clinical trials received from Abbott Vascular, Boston Scientific Corp., Gore & Associates, Inari Medical, Philips-Spectranetics, PQ-Bypass, Reflow Medical, Reva Medical, Terumo, TriReme, Veryan
MT: No conflict of interest
SMH: Speaker fees from Alvimedica, Eurocor, Terumo
KB: No conflict of interest.
ML: Speaker honoraria received from GORE MEDICAL and serves as consultant for GORE MEDICAL.
UB: No conflict of interest.
TB: No conflict of interest.
TZ: Honoraria received from Abbott Vascular, BIBA Medical, Biotronik, Boston Scientific Corp., Cook Medical, Efemoral, Gore & Associates, Medtronic, Philips-Spectranetics, Shockwave, Veryan. Consulted for Boston Scientific Corp., CSI, Gore & Associates, Medtronic, Veryan, Philips-Intact Vascular, Shockwave, Bayer, Vesper Medical, VentureMed, ANT. Institutional Grants for research, clinical trial, or drug studies received from Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Gore & Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, B. Braun; CSI, Boston Scientific, University of Jena, Pluristem, Philips, PQ Bypass, Surmodics, Alative Solutions, Reflow Medical.
The manuscript was not sponsored; however, the study sponsor is W. L. Gore & Associates, Inc. (Gore) Medical Products Division, 1505 North Fourth Street Flagstaff, Arizona, 86004 U.S.A. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewers disclosure
Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.
Supplementary material
Supplemental data for this article can be accessed online at https://doi.org/10.1080/17434440.2023.2214679.
Clinical trial registration
ClinicalTrials.gov n° NCT02907203