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NCT00740207
A Phase IV Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral Digital Subtraction Angiography (DSA)
Phase 4 trial testing VISIPAQUE 270 in Peripheral Arterial Occlusive Disease in 33 participants. Completed in 1 July 2009.
1 July 2009
Quick facts
| Lead sponsor | Bracco Diagnostics, Inc |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | diagnostic |
| Enrollment | 33 |
| Start date | 1 September 2008 |
| Primary completion | 1 July 2009 |
| Estimated completion | 1 July 2009 |
Drugs / interventions tested
- VISIPAQUE 270 (IODIXANOL) — full drug profile →
- Isovue 250 — full drug profile →
Conditions studied
- Peripheral Arterial Occlusive Disease — all drugs for Peripheral Arterial Occlusive Disease →
Sponsor
Bracco Diagnostics, Inc — full company profile →
Who can join
18 and older, any sex, with Peripheral Arterial Occlusive Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Time frame: 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
Sponsor's own description
The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00740207
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Peripheral Arterial Occlusive Disease
Currently open trials in the same condition.
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- NCT05933720 — Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis. · NA · recruiting
Other Bracco Diagnostics, Inc trials
Trials by the same sponsor.
- NCT06400004 — Lumason® Infusion vs. Bolus Administrations · Phase 3 · recruiting
- NCT04453059 — Study With Oral Isovue in Abdominopelvic CT · completed
- NCT04248153 — Optimal Timing of BR55 CEUS of the Ovaries · Phase 2 · terminated
- NCT03779906 — Thyroid Function of Pediatric Subjects Following Isovue® Administration · Phase 4 · terminated
- NCT03493464 — BR55 in Characterization of Ovarian Lesions · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00740207 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bracco Diagnostics, Inc
- Last refreshed: 5 May 2011
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00740207.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing