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临床试验/NCT01861327
NCT01861327Unknown不适用

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

Nelson Wolosker1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Contrastation analysis of the arterial lumen on endovascular procedures using CO2 as contrast media.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • exhibited severe chronic obstructive pulmonary disease (COPD)
  • kidney failure
  • heart failure
  • pregnancy
  • TASC C or D lesions

研究组 & 干预措施

lower limb angioplasty with CO2

Experimental

lower limb angioplasty made with carbon dioxide as contrast media

干预措施: CO2 (Drug)

lower limb angioplasty with Iodine

Active Comparator

lower limb angioplasty made with Iodine as contrast media

干预措施: Iodine contrast media (Drug)

aorto-iliac angioplasty with CO2

Experimental

aorto-iliac angioplasty made with carbon dioxide as contrast media

干预措施: CO2 (Drug)

aorto-iliac angioplasty with Iodine

Active Comparator

aorto-iliac angioplasty made with Iodine as contrast media

干预措施: Iodine contrast media (Drug)

endovascular AAA correction with CO2

Experimental

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

干预措施: CO2 (Drug)

endovascular AAA correction with Iodine

Active Comparator

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

干预措施: Iodine contrast media (Drug)

结局指标

主要结局

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

时间窗: 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).

次要结局

  • clinical outcome: changes in the post-surgery ABI(within 24h of the procedure)

研究者

发起方
Nelson Wolosker
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nelson Wolosker

MD, PHD

Hospital Israelita Albert Einstein

研究点 (1)

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