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Trial record 33 of 671 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

Tracking Information
First Submitted Date  ICMJE February 26, 2013
First Posted Date  ICMJE May 23, 2013
Last Update Posted Date February 24, 2017
Study Start Date  ICMJE April 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01861327 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 21, 2013)
post surgery creatinin clearance measure by the Cockcroft and Gault equation [ Time Frame: within 30 days of the procedure ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures
Official Title  ICMJE The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Lower Limb Ischemia
  • Abdominal Aortic Aneurysms
Intervention  ICMJE
  • Drug: CO2
    carbon dioxide (CO2) as arterial contrast media
  • Drug: Iodine contrast media
    Iodine as arterial contrast media
Study Arms  ICMJE
  • Experimental: lower limb angioplasty with CO2
    lower limb angioplasty made with carbon dioxide as contrast media
    Intervention: Drug: CO2
  • Active Comparator: lower limb angioplasty with Iodine
    lower limb angioplasty made with Iodine as contrast media
    Intervention: Drug: Iodine contrast media
  • Experimental: aorto-iliac angioplasty with CO2
    aorto-iliac angioplasty made with carbon dioxide as contrast media
    Intervention: Drug: CO2
  • Active Comparator: aorto-iliac angioplasty with Iodine
    aorto-iliac angioplasty made with Iodine as contrast media
    Intervention: Drug: Iodine contrast media
  • Experimental: endovascular AAA correction with CO2
    endovascular abdominal aortic aneurysm (AAA) correction made with carbon dioxide as contrast media
    Intervention: Drug: CO2
  • Active Comparator: endovascular AAA correction with Iodine
    endovascular abdominal aortic aneurysm (AAA) correction made with Iodine as contrast media
    Intervention: Drug: Iodine contrast media
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 21, 2013)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2018
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01861327
Other Study ID Numbers  ICMJE CO2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nelson Wolosker, Hospital Israelita Albert Einstein
Study Sponsor  ICMJE Nelson Wolosker
Collaborators  ICMJE Ministério da Saúde
Investigators  ICMJE
Principal Investigator: Nelson Wolosker Hospital Israelita Albert Einstein
PRS Account Hospital Israelita Albert Einstein
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP