The use of carbon dioxide (CO2) as a contrast medium for performing endovascular procedures

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-7v2vvt
• Date of registration: 11/05/2012
• Primary sponsor: Hospital Israelita Albert Einstein - São Paulo, SP, Brazil
• Public title: The use of carbon dioxide (CO2) as a contrast medium for performing endovascular procedures
• Scientific title: The use of carbon dioxide (CO2) as a contrast medium for performing endovascular procedures
• Date of first enrolment: 01/01/2012
• Target sample size: 120
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-7v2vvt/
• Study design: Therapeutic trial, parallel,with 3-arms, single blinded, randomized.

Countries of recruitment

Brazil

Contacts

• Name: Nelson Wolosker
• Affiliation: Hospital Israelita Albert Einstein

• Name: Nelson Wolosker
• Affiliation: Hospital Israelita Albert Einstein

Key inclusion & exclusion criteria

Inclusion criteria: Patients with critical lower limb ischemia resulting from arterial disease morphology TASC A or B or abdominal aortic aneurysms with an indication for the correction ; Agreement and signing the informed consent.

Exclusion criteria: Contraindications to any of the types of procedures either by the technique used, type of contrast or medical reasons.

Age minimum: 18
Age maximum: 0
Gender: -

Health Condition(s) or Problem(s) studied

I00-I99

Lower limb ischemia caused by aortoiliac stenosis, lower limb ischemia due to stenosis of femoropopliteal Abdominal aortic aneurysm with an indication for endovascular repair.
I70
I71.9

Intervention(s)

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 aneury

Primary Outcome(s)

Improve / complete resolution of the patient's condition coupled with the technical feasibility of using carbon dioxide as a contrast medium for performing endovascular procedures for treating patients with vascular disease and lower incidence of side-effects, as evaluated by a lower incidence renal and allergic complications.

Secondary Outcome(s)

Reduced costs of endovascular procedures for treating patients with vascular disease treated by National Health System (SUS), through the use of new contrast medium for lower cost.

Secondary ID(s)

CAAE : 0166.0.028.000-09

Source(s) of Monetary Support

Ministerio da Saude - SP, Brazil

Secondary Sponsor(s)

Hospital Municipal M'boi Mirim - Dr. Moysés Deutsch - Sao Paulo, SP, Brazil