NL-OMON32267已完成4 期
Determination of Diagnostic Accuracy and Added Value of Vasovist®-Enhanced Peripheral MRA in Comparison to Intra-arterial Digital Subtraction Angiography (i.a. DSA) in Patients with Peripheral Artery Disease - Vasovist MA-01
niversity Heidelberg, University Hospital Mannheim0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients who have Fontaine-stage III and IV and an indication for therapeutic i.a. DSA
- •2. PAOD has to be confirmed by ECCM MRA, CTA, non-selective DSA, Doppler ultrasound (DUS) prior to the study.
- •3. Patients who are willing to undergo the study MRA procedure with Vasovist*.
- •4. Patients who are willing to comply with the study procedures (e.g. being followed-up for 12 hours after the Vasovist* injection).
- •5. Patients who have given their fully informed and written consent voluntarily.
排除标准
- •1. Being less than 18 years of age.
- •2. Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same day as administration of Vasovist*. The manufacturer*s instructions for performing the urinary pregnancy test are to be followed.
- •3. Patients who are scheduled for any therapy between any of the two procedures (MRA and DSA) that interferes with the comparability of the two angiographic procedures.
- •4. Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study.
- •5. Having any physical or mental status that interferes with the informed consent procedure including self-signed consent.
- •6. GFR < 30ml/m²/1.73m² (MDRD), values <= 1 week or patients on hemodialysis
- •7. Renal or liver transplant patients, including patients with scheduled liver transplant are excluded due to the potential risk for nephrogenic systemic fibrosis (NSF).
- •8. MR contraindications (pacemaker, magnetic clips, severe claustrophobia)
- •9. Known allergy to Gadofosveset
- •10. Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
- •11. Untreated significant stenosis in pelvis
- •12. Known severe coagulopathy (PTT >25s, Quick < 60%)
- •13. Having received any investigational drug within 7 days prior to entering this study or who are planned to receive any investigational drug during the safety follow-up period.
- •14. Not being able to remain lying down for at least 30-45min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
- •15. Being clinically unstable and whose clinical course during the 12 hours observation period is unpredictable.
- •16. Being scheduled for, or likely to require, any surgical intervention within 12 hours before or within the follow-up period.
- •17. Patients in whom i.a. DSA is contra-indicated preventing him/her from undergoing standard of reference (SOR) procedure.
- •18. Close affiliation with the investigational site; e.g. a close relative of the investigator.
研究者
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Determination of Diagnostic Accuracy and Added Value of Vasovist®-Enhanced Peripheral MRA in Comparison to Intra-arterial Digital Subtraction Angiography (i.a. DSA) in Patients with Peripheral Artery DiseasePatients suffering from PAOD stage III or stage IV (confirmed by ECCM MRA, CTA, non-selective DSA, DUS) and have an indication for the evaluation of the entire lower leg axis down to the feet (common femoral artery to the arteries of the foot) by therapeutic digital subtraction angiography (DSA).MedDRA version: 9.1Level: LLTClassification code 10002939Term: Aortoiliac occlusive diseaseEUCTR2007-006014-41-DEniversity Heidelberg, University Hospital Mannheim145
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