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

NCT ID: NCT01861327

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2018-05-31

Brief Summary

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

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.

Conditions

Critical Lower Limb Ischemia; Abdominal Aortic Aneurysms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

lower limb angioplasty with CO2

lower limb angioplasty made with carbon dioxide as contrast media

Group Type: EXPERIMENTAL

CO2

Intervention Type: DRUG

carbon dioxide (CO2) as arterial contrast media

lower limb angioplasty with Iodine

lower limb angioplasty made with Iodine as contrast media

Group Type: ACTIVE_COMPARATOR

Iodine contrast media

Intervention Type: DRUG

Iodine as arterial contrast media

aorto-iliac angioplasty with CO2

aorto-iliac angioplasty made with carbon dioxide as contrast media

Group Type: EXPERIMENTAL

CO2

Intervention Type: DRUG

carbon dioxide (CO2) as arterial contrast media

aorto-iliac angioplasty with Iodine

aorto-iliac angioplasty made with Iodine as contrast media

Group Type: ACTIVE_COMPARATOR

Iodine contrast media

Intervention Type: DRUG

Iodine as arterial contrast media

endovascular AAA correction with CO2

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

Group Type: EXPERIMENTAL

CO2

Intervention Type: DRUG

carbon dioxide (CO2) as arterial contrast media

endovascular AAA correction with Iodine

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

Group Type: ACTIVE_COMPARATOR

Iodine contrast media

Intervention Type: DRUG

Iodine as arterial contrast media

Interventions

CO2

carbon dioxide (CO2) as arterial contrast media

Intervention Type: DRUG

Iodine contrast media

Iodine as arterial contrast media

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

Nelson Wolosker

OTHER

Sponsor Role: lead

Responsible Party

Nelson Wolosker

MD, PHD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nelson Wolosker

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CO2

Identifier Type: -

Identifier Source: org_study_id