NCT01861327

Brief Summary

Prospective randomized comparison between endovascular procedures performed with iodinated contrast or carbon dioxide as intraarterial contrast.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

February 26, 2013

Last Update Submit

February 23, 2017

Conditions

Critical Lower Limb IschemiaAbdominal Aortic Aneurysms

Keywords

Carbon dioxideaortic aneurysmangioplastyCritical lower limb ischemia

Outcome Measures

Primary Outcomes (1)

  • Contrastation analysis of the arterial lumen on endovascular procedures using CO2 as contrast media.

    image evaluated ranging from 1 (poor -when there was significant loss of definition in the vessels and/or collateral circulation which precluded the procedure), 2 (fair - when there was some loss of definition in the vessels and/or collateral circulation but not impossible to perform the procedure) and 3 (good - when there was good contrast in the vessels and collateral circulation).

    within 2 weeks of the procedure done we will analyze the quality of the images with CO2 and iodine contrast

Secondary Outcomes (1)

  • clinical outcome: changes in the post-surgery ABI

    within 24h of the procedure

Other Outcomes (1)

  • post surgery creatinin clearance measure by the Cockcroft and Gault equation

    within 30 days of the procedure

Study Arms (6)

lower limb angioplasty with CO2

EXPERIMENTAL

lower limb angioplasty made with carbon dioxide as contrast media

Drug: CO2

lower limb angioplasty with Iodine

ACTIVE COMPARATOR

lower limb angioplasty made with Iodine as contrast media

Drug: Iodine contrast media

aorto-iliac angioplasty with CO2

EXPERIMENTAL

aorto-iliac angioplasty made with carbon dioxide as contrast media

Drug: CO2

aorto-iliac angioplasty with Iodine

ACTIVE COMPARATOR

aorto-iliac angioplasty made with Iodine as contrast media

Drug: Iodine contrast media

endovascular AAA correction with CO2

EXPERIMENTAL

endovascular abdominal aortic aneurysm (AAA) correction made with carbon dioxide as contrast media

Drug: CO2

endovascular AAA correction with Iodine

ACTIVE COMPARATOR

endovascular abdominal aortic aneurysm (AAA) correction made with Iodine as contrast media

Drug: Iodine contrast media

Interventions

CO2DRUG

carbon dioxide (CO2) as arterial contrast media

aorto-iliac angioplasty with CO2endovascular AAA correction with CO2lower limb angioplasty with CO2
Iodine contrast mediaDRUG

Iodine as arterial contrast media

aorto-iliac angioplasty with Iodineendovascular AAA correction with Iodinelower limb angioplasty with Iodine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • critical lower limb ischemia resulting from arterial disease morphology TASC A or B or abdominal aortic aneurysms with correction indication
  • Agreement and signing the informed consent.

You may not qualify if:

  • exhibited severe chronic obstructive pulmonary disease (COPD)
  • kidney failure
  • heart failure
  • pregnancy
  • TASC C or D lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalAortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Nelson Wolosker

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PHD

Study Record Dates

First Submitted

February 26, 2013

First Posted

May 23, 2013

Study Start

April 1, 2012

Primary Completion

July 1, 2014

Study Completion

May 1, 2018

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

BR(1)