A Phase IV Pilot 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
- 33
- 主要终点
- Level of Pain in the Lower Extremities Scored by the Participants on the Visual Analog Scale Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
研究概览
简要总结
The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.
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, Care Provider, Investigator)
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
- •Enroll a patient in this study if the patient meets the following inclusion criteria:
- •Provides written Informed Consent and is willing to comply with protocol requirements;
- •Is at least 18 years of age;
- •Is scheduled to undergo peripheral DSA for the diagnosis and/or treatment (PTA) of PAOD.
排除标准
- •Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:
- •Is a pregnant or lactating female. Exclude the possibility of pregnancy:
- •by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of investigational product administration,
- •by surgical history (e.g., tubal ligation or hysterectomy),
- •post menopausal with a minimum 1 year without menses;
- •Has any known allergy to one or more of the ingredients of the investigational products;
- •Has a history of severe congestive heart failure [class IV in accordance with the classification of the New York Heart Association (NYHA)]
- •Was previously entered into this study or received an investigational compound within 30 days before admission into this study;
- •Has a history of hypersensitivity to iodinated contrast agents;
- •Has renal impairment (eGFR <60 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease [MDRD] study equation , );
- •Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations.
研究组 & 干预措施
Isovue 250
干预措施: Isovue 250 (Drug)
VISIPAQUE 270
干预措施: VISIPAQUE 270 (Drug)
结局指标
主要结局
Level of Pain in the Lower Extremities Scored by the Participants on the Visual Analog Scale Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
时间窗: Immediately prior to power injection run and again immediately following power injection run
Visual Analog Scale: Patients were asked to mark on a 10 centimeter line where their pain was in the lower extremity of interest, in relation to the 2 extremes: no pain (0) on the far left and worst pain (10) on the far right. Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10. Patients were assessed immediately prior to injection and again immediately following injection.
次要结局
- The Number of Participants With Motion Artifacts 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)