Prospective clinical study evaluating contemporary MANTA® safety outcomes in India (MANTA® Safety Study in India)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 59
- 试验地点
- 6
- 主要终点
- VCD Large Bore Access-site Related VARC-3 Major & Minor Vascular complications through discharge following TAVR/EVAR/TEVAR procedure (adapted from VARC-3 Criteria 1).
研究概览
简要总结
This is a prospective, multicentre, observational, single-arm study to examine and collect data on safety outcomes of MANTA® large bore closure device in patients undergoing standard of care (SOC) Transcatheter aortic valve replacement (TAVR)/ Endovascular aneurysm repair (EVAR)/ Thoracic Endovascular Aortic Repair (TEVAR) procedures in femoral arterial access sites in India. The patients will be followed up for a period of 1 month. The primary objective is to estimate the percentage of subjects with one or more VARC-3 major and minor vascular complications through discharge following TAVR/EVAR/TEVAR procedure.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Candidate meets criteria for on-label use of MANTA® VCD as specified in MANTA® VCD Instructions for Use (IFU), as per judgement of the investigator.
- •2.Age 21 years & above.
排除标准
- •Before the procedure- 1.Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.
- •2.Severe calcification of the access vessel.
- •3.Severe peripheral artery disease.
- •4.Marked tortuosity of the femoral or iliac artery.
- •5.Patients who cannot be anti-coagulated for the procedure 6.Marked obesity or cachexia (BMI above 40 or below 20).
- •During the TAVR/EVAR/TEVAR procedure- 7.Puncture in the origin of the profundal femoral artery, above the inguinal ligament, or above the most inferior border of the epigastric artery (IEA).
- •8.Sheath insertion in the vessel other than the femoral artery.
- •9.Blood Pressure above 180 mmHg.
结局指标
主要结局
VCD Large Bore Access-site Related VARC-3 Major & Minor Vascular complications through discharge following TAVR/EVAR/TEVAR procedure (adapted from VARC-3 Criteria 1).
时间窗: 1 Month
次要结局
- Additional interventions required at large bore access site to address bleeding or other large bore access site complications (e.g., bare, or(covered stent, or surgical repair) through discharge following TAVR/EVAR/TEVAR)
- VCD Large Bore Access-site Related VARC- 3 Major & Minor Vascular complications within 30 days of TAVR/EVAR/TEVAR(procedure (adapted from VARC-3 Criteria1); reported by Investigators.)
研究者
Dr Deepak Davidson
Caritas Hospital & Institute of Health Sciences