Peripheral Arterial Occlusive DiseasePhase 4NCT00740207

Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA

A Phase 4 study testing VISIPAQUE 270 and Isovue 250 in people with Peripheral Arterial Occlusive Disease, run by Bracco Diagnostics, Inc.

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

The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA. 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?: VISIPAQUE 270 and Isovue 250
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: No sites listed yet
Study dates: Sep 2008to Jul 2009
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

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.

Who cannot join

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;

Show all 11Show fewer

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.

About this study

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

The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.

Conditions: Peripheral Arterial Occlusive Disease
Being tested: VISIPAQUE 270, Isovue 250
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.

VISIPAQUE 270Drug
Also called Iodixanol Injection
VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
Isovue 250Drug
Also called Iopamidol Injection
ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution

Study groups in NCT00740207
Study group	Role	What they receive
Isovue 250	Active comparator	Not described Receives: Drug: Isovue 250
VISIPAQUE 270	Active comparator	Not described Receives: Drug: VISIPAQUE 270

What is being measured

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

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.
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.
Measured: Immediately prior to power injection run and again immediately following power injection run

Secondary outcomes (2)

The Number of Participants With Motion Artifacts 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.
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

Timeline

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

Sep 2008Jul 2009

First posted22 Aug 2008 (estimated)
Study startSep 2008
Primary completionJul 2009
Study completionJul 2009

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, Care provider, Investigator
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00740207
Sponsor's protocol ID: IOP-113
Status last verified: May 2011
First submitted: 20 Aug 2008
Last updated: 9 May 2011
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?

Official record

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

All Peripheral Arterial Occlusive Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral Digital Subtraction Angiography (DSA)
ClinicalTrials.gov ID: NCT00740207
Acronym / sponsor ID: IOP-113
Conditions: Peripheral Arterial Occlusive Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 22 Aug 2008 (estimated)
Results: Posted 18 Apr 2011

Clinical summary

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

The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.

Study design

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

Arm	Type	Receives
Isovue 250	Active comparator	Drug: Isovue 250
VISIPAQUE 270	Active comparator	Drug: VISIPAQUE 270

Who may qualify

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

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (11 listed)

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;

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
VISIPAQUE 270Also: Iodixanol InjectionVISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution	Drug	VISIPAQUE 270
Isovue 250Also: Iopamidol InjectionISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution	Drug	Isovue 250

Primary outcome

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 injection and again immediately following injection.

2 secondary outcomes

The Number of Participants With Motion Artifacts 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

Results and safety

Results posted to the registry on 18 Apr 2011, 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	17	17
VISIPAQUE 270	16	16

Primary outcome: 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. Number. Unit: Participants

Measure	VAS Score Prior to Injection of ISOVUE 250 n = 10	VAS Score After Injection of ISOVUE 250 n = 10	VAS Score Prior to Injection of VISIPAQUE 270 n = 10	VAS Score After Injection of VISIPAQUE 270 n = 10
(0) None	8 (1.35)	6 (1.03)	7	2
(1) Mild	0	1	1	7
(2) Moderate	2	3	2	1
(3) Severe	0	0	0	0

VAS Score After Injection of ISOVUE 250 vs VAS Score After Injection of VISIPAQUE 270: Mean Difference (Final Values): -0.2 (95% CI -1.3 to 0.9), p = 0.7142, t-test, 2 sided

Population analysed: Patients who did not deviate from the planned protocol.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ISOVUE 250	0 of 17 (0%)	1 of 17 (5.9%)	Not reported
VISIPAQUE 270	0 of 16 (0%)	0 of 16 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Arterial Occlusive Disease

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

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.

Steven N. Sireci, MD study chair

Bracco Diagnostics, Inc

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing VISIPAQUE 270 and Isovue 250 in people with Peripheral Arterial Occlusive Disease, run by Bracco Diagnostics, Inc.

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 4 inclusion and 11 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 9 May 2011. Status can change between updates, so confirm with the study contact before making plans.

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 18 Apr 2011). 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 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). 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 NCT00740207.

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 9 May 2011.