The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures

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

Study Overview

• Status: Unknown
• Conditions: Abdominal Aortic Aneurysms; Critical Lower Limb Ischemia
• Intervention / Treatment: Drug: CO2; Drug: Iodine contrast media

Detailed Description

120 patients will undergo endovascular procedures: 40 for the treatment of lower limb ischemia caused by aortoiliac stenosis classified according to the consensus for the management of peripheral arterial disease (TASC) A or B with an indication for angioplasty as the inclusion criteria; 40 for the treatment of lower limb ischemia due to stenosis femoropopliteal TASC A or B with an indication of angioplasty as the inclusion criteria and 40 for the treatment of abdominal aortic aneurysm (AAA) with indication for endovascular repair. Of these procedures, half chosen randomly by computerized simple random, will be submitted to the endovascular procedure in question using only iodinated contrast and the other half will be submitted to the endovascular procedure using carbon dioxide (CO2). There will be no CO2 injection in the aortic arch or cerebral territory. The patient previously evaluated at the Hospital Municipal Dr. Moses Deutsch will be referred to the operating room of the Albert Einstein Hospital where it will be performed under general anesthesia with intubation or blockage associated with sedation, and the same in the supine position (DDH).The femoral artery will be punctured with Seldinger technique unilaterally or bilaterally, according to the indication for the procedure. By using the guide wire will be one or two sheaths inserted in a retrograde manner. Through the introducer, is manually injected retrogradely 50 ml of CO 2, in obtaining images of the apparatus module CO2 Philips mode subtraction angiography. In angioplasty for obstructive disease, with the module roadmap will be held the passage of the guidewire through the stenotic region or occlusion, and dilatation balloon angioplasty specific. After angioplasty, there will be a new injection of contrast for the evaluation of partial results. As appropriate, will be held stent placement, in which case there will be a last angiography with 50 ml of CO2. In endovascular repair of abdominal aortic aneurysms, there will be a first injection of CO2 for the study of the neck of the aneurysm and stent implantation. After the release of the entire stent, a new angiography is performed by injection of CO2 for the control of surgical outcome. In all procedures will be performed to measure pressure through the femoral sheath prior to angioplasty, after angioplasty and stent after the placement. During the use of CO2 as contrast medium, with questions at the trial of such factors as the extent of injury, indication of repair, endoleak, leak, rupture or thrombosis by arteriography will be performed by manual injection of iodinated contrast.Of course this amount of contrast is measured.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical outcome: changes in the post-surgery ABI	Identify changes in ankle-braquial index (ABI) after the procedures	within 24h of the procedure

Other Outcome Measures

Outcome Measure	Time Frame
post surgery creatinin clearance measure by the Cockcroft and Gault equation	within 30 days of the procedure

Collaborators and Investigators

• Sponsor: Nelson Wolosker
• Collaborators: Ministério da Saúde
• Investigators: Principal Investigator: Nelson Wolosker, Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: aortic aneurysm; angioplasty; Carbon dioxide; Critical lower limb ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Ischemia; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: CO2