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

Primary Purpose

Critical Lower Limb Ischemia, Abdominal Aortic Aneurysms

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CO2
Iodine contrast media
Sponsored by
Nelson Wolosker
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Lower Limb Ischemia focused on measuring Carbon dioxide, aortic aneurysm, angioplasty, Critical lower limb ischemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Israelita Albert Einstein

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

lower limb angioplasty with CO2

lower limb angioplasty with Iodine

aorto-iliac angioplasty with CO2

aorto-iliac angioplasty with Iodine

endovascular AAA correction with CO2

endovascular AAA correction with Iodine

Arm Description

lower limb angioplasty made with carbon dioxide as contrast media

lower limb angioplasty made with Iodine as contrast media

aorto-iliac angioplasty made with carbon dioxide as contrast media

aorto-iliac angioplasty made with Iodine as contrast media

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

clinical outcome: changes in the post-surgery ABI
Identify changes in ankle-braquial index (ABI) after the procedures

Full Information

First Posted
February 26, 2013
Last Updated
February 23, 2017
Sponsor
Nelson Wolosker
Collaborators
Ministry of Health, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01861327
Brief Title
The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures
Official Title
The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nelson Wolosker
Collaborators
Ministry of Health, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Lower Limb Ischemia, Abdominal Aortic Aneurysms
Keywords
Carbon dioxide, aortic aneurysm, angioplasty, Critical lower limb ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lower limb angioplasty with CO2
Arm Type
Experimental
Arm Description
lower limb angioplasty made with carbon dioxide as contrast media
Arm Title
lower limb angioplasty with Iodine
Arm Type
Active Comparator
Arm Description
lower limb angioplasty made with Iodine as contrast media
Arm Title
aorto-iliac angioplasty with CO2
Arm Type
Experimental
Arm Description
aorto-iliac angioplasty made with carbon dioxide as contrast media
Arm Title
aorto-iliac angioplasty with Iodine
Arm Type
Active Comparator
Arm Description
aorto-iliac angioplasty made with Iodine as contrast media
Arm Title
endovascular AAA correction with CO2
Arm Type
Experimental
Arm Description
endovascular abdominal aortic aneurysm (AAA) correction made with carbon dioxide as contrast media
Arm Title
endovascular AAA correction with Iodine
Arm Type
Active Comparator
Arm Description
endovascular abdominal aortic aneurysm (AAA) correction made with Iodine as contrast media
Intervention Type
Drug
Intervention Name(s)
CO2
Intervention Description
carbon dioxide (CO2) as arterial contrast media
Intervention Type
Drug
Intervention Name(s)
Iodine contrast media
Intervention Description
Iodine as arterial contrast media
Primary Outcome Measure Information:
Title
Contrastation analysis of the arterial lumen on endovascular procedures using CO2 as contrast media.
Description
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).
Time Frame
within 2 weeks of the procedure done we will analyze the quality of the images with CO2 and iodine contrast
Secondary Outcome Measure Information:
Title
clinical outcome: changes in the post-surgery ABI
Description
Identify changes in ankle-braquial index (ABI) after the procedures
Time Frame
within 24h of the procedure
Other Pre-specified Outcome Measures:
Title
post surgery creatinin clearance measure by the Cockcroft and Gault equation
Time Frame
within 30 days of the procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Wolosker
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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