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Safety and effectiveness of the Chocolate balloon catheter in the treatment of peripheral artery disease with percutaneous transluminal angioplasty: a multicentre, prospective, observational study protocol

Por: Ye · Z.-Q. · Liu · H. · Fang · X. · Meng · X.-H.
Background

Peripheral artery disease (PAD) represents a significant global health burden. Percutaneous transluminal angioplasty (PTA) is the most commonly employed endovascular intervention; however, its long-term efficacy is often compromised by restenosis and flow-limiting dissection. The Chocolate balloon catheter, characterised by a nitinol-constrained design that enables controlled, segmental vessel dilation, has demonstrated potential in minimising vascular trauma and enhancing patency. Nevertheless, there remains a lack of robust multicentre evidence evaluating its safety and effectiveness in real-world Chinese PAD populations. This protocol outlines a prospective, multicentre, single-arm observational study aiming to assess the 12 month primary patency and complication rates following Chocolate balloon PTA in Chinese patients with femoropopliteal or infrapopliteal lesions.

Methods and analysis

This prospective, multicentre, single-arm observational study will be conducted across eight medical centres in China. Eligible patients with symptomatic PAD (Rutherford classification 2–5) and de novo or restenotic lesions in the femoropopliteal or infrapopliteal arteries, for whom the use of a Chocolate balloon catheter is indicated as per standard care, will be enrolled. All participants will undergo percutaneous transluminal angioplasty using the Chocolate balloon catheter and will be followed up for 12 months. The primary outcome is the primary patency rate of the target lesion at 12 months, defined as the absence of restenosis (diameter stenosis

Ethics and dissemination

The study protocol was approved by the Clinical Trial Ethics Committee of Hangzhou First People’s Hospital (Approval No. IIT-20220606-0082-01). The findings will be disseminated in peer-reviewed publications.

Trial registration number

NCT06933992.

Application of Haos Esophagogastrostomy by Fissure Technique (HEFT) in proximal gastrectomy: protocol for a prospective, multicentre, randomised controlled study

Por: Cui · W.-l. · Wang · Z.-Q. · Shi · X.-L. · Ma · M.-Y. · Wang · J. · Wang · Z.-H. · Wang · Y.-P. · Hong · J. · Hao · H.-K.
Background

Proximal gastrectomy (PG) has emerged as the preferred surgical approach for adenocarcinoma of the upper 1/3 stomach and selected cases of oesophagogastric junction adenocarcinoma. We developed a novel oesophagogastric anastomosis technique with an antireflux mechanism (Hao’s Esophagogastrostomy by Fissure Technique). It may have a superior effect on patient weight maintenance compared with the double-tract reconstruction. We intend to conduct a prospective, multicentre, randomised controlled clinical trial to validate this hypothesis.

Methods and analysis

The primary objective evaluates body weight loss at 12 months postoperatively. Secondary objectives assess surgical safety through comprehensive analysis of complication rates and nutritional parameters, including serial haematological evaluations during follow-up. The study will enrol 52 participants across multiple centres with planned 3-year longitudinal monitoring to evaluate both immediate postoperative outcomes and intermediate-term clinical impacts.

Ethics and dissemination

This study was approved by the hospital institutional review board of Huashan Hospital, Fudan University (2024-1173) and is being conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines. On completion of the study, the results will be published in a peer-reviewed journal.

Trial registration number

NCT06679244.

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