Isovue in Peripheral Digital Subtraction Angiography (DSA)

NCT01075217 | Completed Phase 4 Results

• 1 other identifier: IOP 119
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

No significant differences is expected in observed motion artifacts, heat or pain reported during peripheral DSA performed for diagnostic and/or endovascular therapeutic purposes.

Conditions

Peripheral Arterial Occlusive Disease

Keywords

Peripheral arterial occlusive disease (PAOD)

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  immediately after administration of agent using a power injector for the administration

Secondary Outcomes (4)

• 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

Study Arms (2)

Isovue 250 (iopamidol)

EXPERIMENTAL

Drug: iopamidol

Visipaque 270 (iodixanol)

ACTIVE COMPARATOR

Drug: iodixanol

Interventions

iopamidol DRUG

Participants received at least one intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).

Also known as: Other name: Isovue 250

Isovue 250 (iopamidol)

iodixanol DRUG

Participants received at least one intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).

Also known as: Other name: Visipaque 270

Visipaque 270 (iodixanol)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• provides written informed consent;
• at least 18 years of age;
• scheduled to undergo peripheral DSA for the diagnosis and/or treatment of PAOD

You may not qualify if:

• 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

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Bracco Diagnostics

Princeton, New Jersey, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Interventions

Iopamidol; iodixanol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Usha Halemane
• Organization: Bracco Diagnostics Inc

Usha.Halemane@diag.bracco.com

609.514.2578

Study Officials

• Martin Krix, M.D.

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 25, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 30, 2013
• Results First Posted: May 23, 2013

Record last verified: 2012-04

Locations

US (1)