Critical Lower Limb IschemiaNCT01861327
The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures
A study testing CO2 and Iodine contrast media in people with Critical Lower Limb Ischemia and Abdominal Aortic Aneurysms, run by Nelson Wolosker at 1 site in Brazil.
Trial summary
Prospective randomized comparison between endovascular procedures performed with iodinated contrast or carbon dioxide as intraarterial contrast. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Lower Limb Ischemia, Abdominal Aortic Aneurysms
- What is being tested?
- CO2 and Iodine contrast media
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2012to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- exhibited severe chronic obstructive pulmonary disease (COPD)
- kidney failure
- heart failure
- pregnancy
- TASC C or D lesions
Trial locations and contacts
1 site in 1 country.
About this study
Prospective randomized comparison between endovascular procedures performed with iodinated contrast or carbon dioxide as intraarterial contrast.
Read the 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.
- Being tested
- CO2, Iodine contrast media
- Keywords
- Carbon dioxide, aortic aneurysm, angioplasty, Critical lower limb ischemia
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2Drug
carbon dioxide (CO2) as arterial contrast media
Iodine contrast mediaDrug
Iodine as arterial contrast media
| Study group | Role | What they receive |
|---|---|---|
| lower limb angioplasty with CO2 | Experimental | lower limb angioplasty made with carbon dioxide as contrast media Receives: Drug: CO2 |
| lower limb angioplasty with Iodine | Active comparator | lower limb angioplasty made with Iodine as contrast media Receives: Drug: Iodine contrast media |
| aorto-iliac angioplasty with CO2 | Experimental | aorto-iliac angioplasty made with carbon dioxide as contrast media Receives: Drug: CO2 |
| aorto-iliac angioplasty with Iodine | Active comparator | aorto-iliac angioplasty made with Iodine as contrast media Receives: Drug: Iodine contrast media |
| endovascular AAA correction with CO2 | Experimental | endovascular abdominal aortic aneurysm (AAA) correction made with carbon dioxide as contrast media Receives: Drug: CO2 |
| endovascular AAA correction with Iodine | Active comparator | endovascular abdominal aortic aneurysm (AAA) correction made with Iodine as contrast media Receives: Drug: Iodine contrast media |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within 2 weeks of the procedure done we will analyze the quality of the images with CO2 and iodine contrast
Secondary outcomes (1)
clinical outcome: changes in the post-surgery ABI
Identify changes in ankle-braquial index (ABI) after the procedures
Measured: within 24h of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startApr 2012
- Primary completionJul 2014
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Lower Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nelson Wolosker
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor-investigator, Nelson Wolosker, Hospital Israelita Albert Einstein
- Investigators
- Nelson Wolosker, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861327
- Sponsor's protocol ID
- CO2
- Status last verified
- Feb 2017
- First submitted
- 26 Feb 2013
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures
- ClinicalTrials.gov ID
- NCT01861327
- Acronym / sponsor ID
- CO2
- Keywords
- Carbon dioxide, aortic aneurysm, angioplasty, Critical lower limb ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nelson WoloskerUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- Apr 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- May 2018 (estimated)
- First posted
- 23 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| lower limb angioplasty with CO2 | Experimental | Drug: CO2lower limb angioplasty made with carbon dioxide as contrast media |
| lower limb angioplasty with Iodine | Active comparator | Drug: Iodine contrast medialower limb angioplasty made with Iodine as contrast media |
| aorto-iliac angioplasty with CO2 | Experimental | Drug: CO2aorto-iliac angioplasty made with carbon dioxide as contrast media |
| aorto-iliac angioplasty with Iodine | Active comparator | Drug: Iodine contrast mediaaorto-iliac angioplasty made with Iodine as contrast media |
| endovascular AAA correction with CO2 | Experimental | Drug: CO2endovascular abdominal aortic aneurysm (AAA) correction made with carbon dioxide as contrast media |
| endovascular AAA correction with Iodine | Active comparator | Drug: Iodine contrast mediaendovascular abdominal aortic aneurysm (AAA) correction made with Iodine as contrast media |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- exhibited severe chronic obstructive pulmonary disease (COPD)
- kidney failure
- heart failure
- pregnancy
- TASC C or D lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2carbon dioxide (CO2) as arterial contrast media | Drug | aorto-iliac angioplasty with CO2, endovascular AAA correction with CO2, lower limb angioplasty with CO2 |
| Iodine contrast mediaIodine as arterial contrast media | Drug | aorto-iliac angioplasty with Iodine, endovascular AAA correction with Iodine, lower limb angioplasty with Iodine |
Primary outcome
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).
1 secondary outcome
clinical outcome: changes in the post-surgery ABI
Time frame: within 24h of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelson Wolosker principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 and Iodine contrast media in people with Critical Lower Limb Ischemia and Abdominal Aortic Aneurysms, run by Nelson Wolosker at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.