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

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

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

Interventional

Primary Outcome

Contrastation analysis of the arterial lumen on endovascular procedures using CO2 as contrast media.

Secondary Outcome

 clinical outcome: changes in the post-surgery ABI

Condition

Critical Lower Limb Ischemia

Intervention

CO2

Study Arms / Comparison Groups

 lower limb angioplasty with CO2

Description:  lower limb angioplasty made with carbon dioxide as contrast media

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

120

Start Date

April 2012

Completion Date

May 2018

Primary Completion Date

July 2014

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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Nelson Wolosker, , 

Location Countries

Brazil

Location Countries

Brazil

NCT ID

NCT01861327

Organization ID

CO2

Responsible Party

Sponsor-Investigator

Study Sponsor

Nelson Wolosker

Collaborators

 Ministério da Saúde

Study Sponsor

Nelson Wolosker, Principal Investigator, Hospital Israelita Albert Einstein

Verification Date

February 2017