Peripheral Arterial Occlusive DiseasePhase 4NCT01075217

Isovue in Peripheral Digital Subtraction Angiography (DSA)

A Phase 4 study testing iopamidol and iodixanol in people with Peripheral Arterial Occlusive Disease, run by Bracco Diagnostics, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Occlusive Disease
What is being tested?: iopamidol and iodixanol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 174 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Dec 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Bracco Diagnostics
Princeton, New Jersey

Other trials in United States

About this study

Official title: A Phase IV Multi-Center Study to Compare ISOVUE -250 and VISIPAQUE 270 for Motion Artifact and Pain in Peripheral Digital Subtraction Angiography (DSA)

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
Being tested: iopamidol, iodixanol
Keywords: Peripheral arterial occlusive disease (PAOD)
Medical subject headings: Peripheral Arterial Occlusive Disease 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iopamidolDrug
Also called Other name: Isovue 250
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).
iodixanolDrug
Also called Other name: Visipaque 270
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).

Study groups in NCT01075217
Study group	Role	What they receive
Isovue 250 (iopamidol)	Experimental	Not described Receives: Drug: iopamidol
Visipaque 270 (iodixanol)	Active comparator	Not described Receives: Drug: iodixanol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
The 10-centimeter Heat VAS was completed by the Group 2 patients to assess his/her heat level (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 heat and the right end (10 cm) of the scale indicating the worst heat.
The Heat VAS was completed by the patient before completing the Pain VAS to assess pain.
Measured: 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.
Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable. Scores of 3 and 4 were counted as significant motion artifacts.
Measured: Immediately postdose
The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.
Measured: Immediately postdose
The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA
The Investigator assessed all study images obtained for each patient using a 2-point scale (1 = adequate quality; 2 = inadequate quality); assessment was independent of factors or problems relating to the underlying patient condition or the imaging parameters selected.
Results are provided for patients with adequate quality.
Measured: Immediately postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Dec 2011

First posted25 Feb 2010 (estimated)
Study startApr 2010
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01075217
Sponsor's protocol ID: IOP 119
Status last verified: Apr 2012
First submitted: 23 Feb 2010
Last updated: 30 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study
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All Peripheral Arterial Occlusive Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV Multi-Center Study to Compare ISOVUE -250 and VISIPAQUE 270 for Motion Artifact and Pain in Peripheral Digital Subtraction Angiography (DSA)
ClinicalTrials.gov ID: NCT01075217
Acronym / sponsor ID: IOP 119
Conditions: Peripheral Arterial Occlusive Disease
Keywords: Peripheral arterial occlusive disease (PAOD)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 174 participants (actual)
Lead sponsor: Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 25 Feb 2010 (estimated)
Results: Posted 23 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Isovue 250 (iopamidol)	Experimental	Drug: iopamidol
Visipaque 270 (iodixanol)	Active comparator	Drug: iodixanol

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iopamidolAlso: Other name: Isovue 250Participants 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).	Drug	Isovue 250 (iopamidol)
iodixanolAlso: Other name: Visipaque 270Participants 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).	Drug	Visipaque 270 (iodixanol)

Primary outcome

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
Time frame: 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.

4 secondary outcomes

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
Time frame: 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.
Time frame: Immediately postdose
The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
Time frame: Immediately postdose
The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA
Time frame: Immediately postdose

Results and safety

Results posted to the registry on 23 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Isovue 250	84	82
Visipaque 270	85	84

Primary outcome: 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

Time frame: immediately after administration of agent using a power injector for the administration. Mean (Standard Deviation). Unit: centimeters

Measure	Isovue 250 VAS Score Prior to Injection (Baseline) n = 77	Isovue 250 VAS Score Immediately After Injection n = 77	Visipaque 270 VAS Score Prior to Injection (Baseline) n = 82	Visipaque 270 VAS Score Immediately After Injection n = 82
Group 1 pain and heat not separate (n=42,42,48,48)	0.6 (1.64)	3.1 (3.20)	0.3 (0.87)	0.7 (1.52)
Group 2 pain and heat separate (n=35,35,34,34)	0.4 (1.5)	1.2 (2.10)	0.2 (0.77)	0.8 (1.76)

Isovue 250 VAS Score Immediately After Injection vs Visipaque 270 VAS Score Immediately After Injection: Mean Difference (Final Values): 2.5 (95% CI 1.4 to 3.5), p <0.0001, t-test, 2 sided
Isovue 250 VAS Score Immediately After Injection vs Visipaque 270 VAS Score Immediately After Injection: Mean Difference (Final Values): 0.5 (95% CI -0.5 to 1.4), p = 0.3244, t-test, 2 sided

Population analysed: Patients who received study agent, had the corresponding endpoint evaluations available and had no deviations from the planned protocol were included in the analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Start of investigational product administration through the follow-up period of 1 hour post-injection. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Isovue 250	1 of 84 (1.2%)	6 of 84 (7.1%)	Not reported
Visipaque 270	1 of 85 (1.2%)	1 of 85 (1.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Arterial Occlusive Disease

Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
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Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martin Krix, M.D. study director

Bracco Diagnostics, Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing iopamidol and iodixanol in people with Peripheral Arterial Occlusive Disease, run by Bracco Diagnostics, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: immediately after administration of agent using a power injector for the administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01075217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013; AzTrials last refreshed its copy on 31 Oct 2026.