Overview

This trial is active, not recruiting.

Conditions critical lower limb ischemia, abdominal aortic aneurysms
Treatments co2, iodine contrast media
Sponsor Nelson Wolosker
Collaborator Ministério da Saúde
Start date April 2012
End date July 2014
Trial size 120 participants
Trial identifier NCT01861327, CO2

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
lower limb angioplasty made with carbon dioxide as contrast media
co2
carbon dioxide (CO2) as arterial contrast media
(Active Comparator)
lower limb angioplasty made with Iodine as contrast media
iodine contrast media
Iodine as arterial contrast media
(Experimental)
aorto-iliac angioplasty made with carbon dioxide as contrast media
co2
carbon dioxide (CO2) as arterial contrast media
(Active Comparator)
aorto-iliac angioplasty made with Iodine as contrast media
iodine contrast media
Iodine as arterial contrast media
(Experimental)
endovascular abdominal aortic aneurysm (AAA) correction made with carbon dioxide as contrast media
co2
carbon dioxide (CO2) as arterial contrast media
(Active Comparator)
endovascular abdominal aortic aneurysm (AAA) correction made with Iodine as contrast media
iodine contrast media
Iodine as arterial contrast media

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
clinical outcome: changes in the post-surgery ABI
time frame: within 24h of the procedure

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures
Principal investigator Nelson Wolosker
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Hospital Israelita Albert Einstein.