Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions
报名条件（概要）
- 年龄：18 Years – 80 Years
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
药品与企业信息
Drug-eluting stents meeting study criteria (e.g., sirolimus-, paclitaxel-, or everolimus-eluting stents; specific models selected by operators according to clinical practice) were chosen. Stent diameter was determined by the target vessel reference diameter (2.25-4.0 mm), with length covering the occluded segment plus 5 mm of healthy vessel proximal and distal to the lesion. Stents were deployed at 8-16 atm to ensure optimal apposition. Intraoperative angiography confirmed no residual stenosis (\<10%) and TIMI grade 3 flow. When multiple stents were required, an overlapping technique was utilized to ensure complete lesion coverage.
Drug-coated balloons meeting study criteria (e.g., paclitaxel- or sirolimus-coated DCB; specific models selected by operators according to clinical practice) were chosen. DCB diameter was determined by the target vessel reference diameter (2.25-4.0 mm), with length covering the occluded segment plus 5 mm proximal and distal to the lesion. DCB inflation was maintained for ≥60 seconds at 8-12 atm to ensure adequate drug delivery to the vessel wall. Intraoperative angiography confirmed \<50% residual stenosis, TIMI grade 3 flow, and absence of serious complications. DES implantation was permitted (recorded as hybrid strategy) if any of the following conditions occurred after DCB application: Residual stenosis ≥50% with hemodynamic significance; Non-flow-limiting dissection requiring stent support based on operator judgment; Other technical difficulties resulting in DCB-alone treatment failure. DES selection was consistent with the DES-only group.
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
The aim of this study is to evaluate the long-term efficacy and safety of drug-coated balloon (DCB) strategies, including DCB alone or hybrid strategies of DCB and drug-eluting stent (DES), compared to DES-only in patients with chronic total occlusion (CTO) after successful recanalization. Through a prospective, multicenter randomized controlled trial, we will directly compare the long-term outcomes of these two treatment strategies in CTO patients to fill the gap in existing research regarding direct comparative data between DCB and DES in CTO treatment. This study expects to provide high-quality evidence for optimizing CTO treatment, potentially improving treatment strategies in complex cases, reducing stent usage, lowering the risk of complications, and ultimately enhancing patient prognosis.
适应症
主动联系研究团队
总联系人（申办方／研究总部）
- Liang Pan, Doctorhuzhoupanliang@163.com+86-15003851743
中国／港澳台研究中心
- Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)Beijing，Beijing Municipality，China
- Anyang District HospitalAnyang，Henan，China
- The People's Hospital of JiaozuoJiaozuo，Henan，China
- The second people's Hospital of JiyuanJiyuan，Henan，China
- Huaihe Hospital of Henan UniversityKaifeng，Henan，China
- Kaifeng Central HospitalKaifeng，Henan，China
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions ClinicalTrials.gov Identifier: NCT07463664 Sponsor: The First Affiliated Hospital of Zhengzhou University Investigational product: DES Implantation, DCB Angioplasty About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions 试验编号：NCT07463664 申办方：The First Affiliated Hospital of Zhengzhou University 研究药物：DES Implantation、DCB Angioplasty 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
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下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
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- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。