The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures
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ClinicalTrials.gov Identifier: NCT01861327 |
Recruitment Status : Unknown
Verified February 2017 by Nelson Wolosker, Hospital Israelita Albert Einstein.
Recruitment status was: Active, not recruiting
First Posted : May 23, 2013
Last Update Posted : February 24, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Critical Lower Limb Ischemia Abdominal Aortic Aneurysms | Drug: CO2 Drug: Iodine contrast media | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | July 2014 |
Estimated Study Completion Date : | May 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: lower limb angioplasty with CO2
lower limb angioplasty made with carbon dioxide as contrast media
|
Drug: CO2
carbon dioxide (CO2) as arterial contrast media |
Active Comparator: lower limb angioplasty with Iodine
lower limb angioplasty made with Iodine as contrast media
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Drug: Iodine contrast media
Iodine as arterial contrast media |
Experimental: aorto-iliac angioplasty with CO2
aorto-iliac angioplasty made with carbon dioxide as contrast media
|
Drug: CO2
carbon dioxide (CO2) as arterial contrast media |
Active Comparator: aorto-iliac angioplasty with Iodine
aorto-iliac angioplasty made with Iodine as contrast media
|
Drug: Iodine contrast media
Iodine as arterial contrast media |
Experimental: endovascular AAA correction with CO2
endovascular abdominal aortic aneurysm (AAA) correction made with carbon dioxide as contrast media
|
Drug: CO2
carbon dioxide (CO2) as arterial contrast media |
Active Comparator: endovascular AAA correction with Iodine
endovascular abdominal aortic aneurysm (AAA) correction made with Iodine as contrast media
|
Drug: Iodine contrast media
Iodine as arterial contrast media |
- Contrastation analysis of the arterial lumen on endovascular procedures using CO2 as contrast media. [ Time Frame: within 2 weeks of the procedure done we will analyze the quality of the images with CO2 and iodine contrast ]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).
- clinical outcome: changes in the post-surgery ABI [ Time Frame: within 24h of the procedure ]Identify changes in ankle-braquial index (ABI) after the procedures
- post surgery creatinin clearance measure by the Cockcroft and Gault equation [ Time Frame: within 30 days of the procedure ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- exhibited severe chronic obstructive pulmonary disease (COPD)
- kidney failure
- heart failure
- pregnancy
- TASC C or D lesions

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861327
Brazil | |
Hospital Israelita Albert Einstein | |
São Paulo, SP, Brazil |
Principal Investigator: | Nelson Wolosker | Hospital Israelita Albert Einstein |
Responsible Party: | Nelson Wolosker, MD, PHD, Hospital Israelita Albert Einstein |
ClinicalTrials.gov Identifier: | NCT01861327 |
Other Study ID Numbers: |
CO2 |
First Posted: | May 23, 2013 Key Record Dates |
Last Update Posted: | February 24, 2017 |
Last Verified: | February 2017 |
Carbon dioxide aortic aneurysm angioplasty Critical lower limb ischemia |
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Ischemia |
Pathologic Processes Vascular Diseases Cardiovascular Diseases Aortic Diseases |