MOVE - Mobilization and Outcomes After VEnous Closure - A Prospective Registry of Real-World Outcomes/Usage/Evidence for the MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 13
- 主要终点
- Rate of access-site complications
研究概览
简要总结
The primary objective of this post-market registry is to collect real-world outcomes and evaluate usage practice of MYNX CONTROL™ VENOUS (MCV) Vascular Closure Device (VCD) 6F-12F in sealing femoral venous access sites in patients who have undergone endovascular procedures in a real-world setting.
详细描述
The study is a single-arm, prospective, multi-center, observational, real-world registry of venous access site closures utilizing MYNX CONTROL™ VENOUS VCD 6F-12F following endovascular procedures. The study will enroll approximately 300 subjects in approximately 15 study sites in the United States.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide informed consent and to complete a follow-up visit at 14 ± 7 days post-procedure.
- •Individuals undergoing catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple venous access sites in one or both limbs.
- •Individuals who are candidates to have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU.
- •At the time of enrollment, the Investigator deems the subject a candidate for same-day discharge (SDD) per standard of care (no procedure related events/complications e.g., no new pericardial effusion, post-procedure diuresis not needed, etc.).
排除标准
- •Presence of bruit, palpable aneurysm, significant candida or groin infection.
- •Prior to closure, presence of hematoma in the accessed limb.
- •Currently involved in any other clinical trial that may interfere with the outcomes of this study as determined by the Investigator.
- •Planned use of other closure devices or techniques other than MYNX CONTROL™ VENOUS VCD 6F-12F.
- •Life expectancy <12 months.
研究组 & 干预措施
MCV VCD Treatment
Subjects who undergo catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple venous access sites in one or both limbs, and have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU.
干预措施: MYNX CONTROLTM VENOUS Vascular Closure Device (Device)
结局指标
主要结局
Rate of access-site complications
时间窗: From time of study device introduction at first access site through 14 days post-procedure
Rate of access-site complications, assessed per standard of care, through 14 days post-procedure, including: * Access Site-Related Hematoma \> 6 cm documented by ultrasound * Local Access Site Infection confirmed by culture and sensitivity, treated with intramuscular or oral antibiotics * Allergic Reaction * Access site-related bleeding requiring transfusion, surgical intervention, or rehospitalization * Pulmonary embolism requiring surgical or endovascular intervention and/or resulting in death, to be confirmed by CT pulmonary angiography, lung ventilation/perfusion scan (VQ scan), or autopsy * Ipsilateral deep vein thrombosis, documented by ultrasound
Rate of patients with same day discharge (SDD) and without subsequent hospitalization/intervention for access-site complications
时间窗: From time of index procedure through end of following day (within 48 hours)
Rate of patients who successfully received a study device at all access sites and had SDD without subsequent hospitalization/intervention for access-site complications either same day post-discharge or the next day
次要结局
未报告次要终点