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Trial record 33 of 667 for:    CARBON DIOXIDE AND arterial

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
Sponsor:
Collaborator:
Ministério da Saúde
Information provided by (Responsible Party):
Nelson Wolosker, Hospital Israelita Albert Einstein

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

Condition or disease Intervention/treatment Phase
Critical Lower Limb Ischemia Abdominal Aortic Aneurysms Drug: CO2 Drug: Iodine contrast media Not Applicable

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.

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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
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

Information from the National Library of Medicine

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


Locations
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Brazil
Hospital Israelita Albert Einstein
São Paulo, SP, Brazil
Sponsors and Collaborators
Nelson Wolosker
Ministério da Saúde
Investigators
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Principal Investigator: Nelson Wolosker Hospital Israelita Albert Einstein

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Responsible Party: Nelson Wolosker, MD, PHD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT01861327     History of Changes
Other Study ID Numbers: CO2
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Keywords provided by Nelson Wolosker, Hospital Israelita Albert Einstein:
Carbon dioxide
aortic aneurysm
angioplasty
Critical lower limb ischemia
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs