A Phase IV Multi-Center Study to Compare ISOVUE -250 and VISIPAQUE 270 for Motion Artifact and Pain in Peripheral Digital Subtraction Angiography (DSA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Level of Pain/Heat in the Lower Extremities Scored by the Participants on the Visual Analog Scale (VAS) Following Intra-arterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA
研究概览
简要总结
No significant differences is expected in observed motion artifacts, heat or pain reported during peripheral DSA performed for diagnostic and/or endovascular therapeutic purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •provides written informed consent;
- •at least 18 years of age;
- •scheduled to undergo peripheral DSA for the diagnosis and/or treatment of PAOD
排除标准
- •pregnant or lactating female;
- •known allergies to one more more ingredients in wither product;
- •history of severe congestive heart failure (Class IV);
- •previously enrolled or received an investigational compound within 30 days;
- •history of hypersensitivity to iodinated contrast agents;
- •renal impairment eGFR <60 mL/min/1.73m2, calculated using the MDRD study equation
- •any other medical condition decreasing chances of obtaining reliable data
研究组 & 干预措施
Isovue 250 (iopamidol)
干预措施: iopamidol (Drug)
Visipaque 270 (iodixanol)
干预措施: iodixanol (Drug)
结局指标
主要结局
Level of Pain/Heat in the Lower Extremities Scored by the Participants on the Visual Analog Scale (VAS) Following Intra-arterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA
时间窗: immediately after administration of agent using a power injector for the administration
The 10-centimeter Pain VAS was completed by the Group 1 patients to assess his/her pain level (not scoring heat separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain. The 10-centimeter Pain VAS (excluding Heat assessment, which was separately assessed) was completed by the Group 2 patients to assess his/her pain level in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain. Group 1 completed the Pain VAS (heat not separate from pain). Group 2 completed the Pain VAS for pain only and, separately, the Heat VAS for heat only.
次要结局
- Level of Heat in the Lower Extremities Scored by Group 2 as Assessed on the Heat VAS Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA(Immediately after administration of agent using a power injector for the administration)
- The Number of Participants With Significant Motion Artifacts (Scores of 3 or 4) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.(Immediately postdose)
- The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.(Immediately postdose)
- The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA(Immediately postdose)