Atherosclerosis of the Peripheral ArteriesNCT02580084
Clinical Study of the Aorta-femoral Bypass and Hybrid Intervention and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery Effectiveness in Patients With the Iliac Segment and Femoral Artery Occlusive Disease (TASC C, D)
A study testing Hybrid Intervention and Aorta femoral Bypass in people with Atherosclerosis of the Peripheral Arteries, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Currently, according to the TASC II consensus document (2007) and the Russian guidelines for limb ischemia treatment (2010), aorta-iliac C and D type segment lesions the open surgery is suggested. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atherosclerosis of the Peripheral Arteries
- What is being tested?
- Hybrid Intervention and Aorta femoral Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteRussia
- Study dates
- Aug 2015to Mar 2021
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with occlusive lesions of C and D type iliac segment and steno-occlusive lesions of the common femoral artery, and with chronic lower limb ischemia (II-IV degree by Fontaine, 2-5 degree by Rutherford), age: 47-75 years old.
- Patients who consented to participate in this study
Who cannot join
- Chronic heart failure of III-IV functional class by New York Heart Association classification.
- Patients who have suffered a stroke or myocardial infarction less than 3 months
- Significant Steno-occlusive lesion of the contralateral side
- Decompensated chronic "pulmonary" heart
- Aortoarteritis
- Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min);
Show all 10Show fewer
- Polyvalent drug allergy
- Cancer in the terminal stage with a life expectancy less than 6 months
- Expressed aortic calcification tolerant to angioplasty
- Patient refusal to participate or continue to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Study of the Aorta-femoral Bypass and Hybrid Intervention and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery Effectiveness in Patients With the Iliac Segment and Femoral Artery Occlusive Disease (TASC C, D)
Currently, according to the TASC II consensus document (2007) and the Russian guidelines for limb ischemia treatment (2010), aorta-iliac C and D type segment lesions the open surgery is suggested.
Read the detailed description
Currently, according to the TASC II consensus document (2007) and the Russian guidelines for limb ischemia treatment (2010), aorta-iliac C and D type segment lesions the open surgery is suggested.
According to different studies, 76% occlusive aorta-iliac article course patients indicate femoral-popliteal segment lesions. Due to the lack of inflow and outflow ways of correction needed for adequate limb revascularization surgery treatment of multistorey atherosclerotic lesions patients is still one of the most complex problems of vascular surgery. Perioperational mortality of critical limb ischemia patients reaches 5-10% in retrograde aorta-iliac segment reconstruction.
Due to its high efficiency hybrid operative invasion is one of the most perspective directions in reconstructive vascular surgery development (92-98% of the cases with the small number of post-operative complications).
Furthermore, hybrid surgery is possible with the critical iliac segment and femoral artery lesions, since stenting in the field of physiological bends (femoral artery) may lead to its breaking and artery thrombosis. Arterial segments blood flow reconstruction is possible with hybrid innervations meaning iliac segment stenting and common femoral artery patch.
All reports of iliac arteries stenosis percutaneous angioplasty indicate that the primary technical and clinical success rate exceeds 90%. The technical success of iliac arteries long occlusions recanalization reaches 80-85%. Improvement of endovascular equipment designed for the total occlusions treatment increases technical success of recanalization. The TASC II materials summarize the several large studies results which present the data on the operated segment artery patency at the level of 70-81% within 5-8 years of follow up. A large number of authors note the actuality of aortic-iliac type C and D segment lesions endovascular treatment recommendations revision according to the TASC II, together with hybrid technics implementation in this category of patients.
- Being tested
- Hybrid Intervention, Aorta femoral Bypass
- Keywords
- atherosclerosis of the peripheral arteries, Aorta-femoral Bypass, Hybrid Intervention, Iliac Arteries With Stenting and Plasty of the Common Femoral Artery, plastic arteries with lesions of the common femoral artery and deep femoral artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid InterventionProcedure or surgery
The puncture of the femoral artery general is executed and the introducer 7Fr is set. Further, the hydrophilic conductor executes a recanalization of the Vasa of iliac artery occlusion. if you cannot pass the occlusion retrograde is additional access to antegrade recanalization. Then using hydrophilic conductors, an iliac artery antegrade or retrograde recanalization of the Vasa is made.
Femoral artery arteriotomy. Further execute a direct endarterectomy femoral artery and from the mouth of a hip artery.
arteriotomy of the femoral artery is closed with a vascular patch use (synthetic or biological).
Balloon angioplasty and stenting, iliac artery is done, the controlling angiography Closing maims.
Aorta femoral BypassProcedure or surgery
It is sufficient to identify only the anterior-lateral aorta surface. After heparinization the aorta is clamped above and below the anastomosis. The aorta is dissected along the anterior wall, calcium portions or mural thrombus are removed. Prosthesis is cut obliquely and anastomosis suturing starts with distal angle. Occluded at the prosthetic base jaws, aortic compressor is removed, restoring blood flow in the lower limb. Next stage is tunnel creating for jaws prosthesis conduction on hip. Ureters must remain over the prosthesis, jaw should be above the iliac arteries. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. Before anastomosis completion the testing jaws and all arteries bloodletting is performed.
| Study group | Role | What they receive |
|---|---|---|
| aorta femoral bypass | Active comparator | It is sufficient to identify only the anterior-lateral aorta surface. After heparinization the aorta is clamped above and below the anastomosis. The aorta is dissected along the anterior wall, calcium portions or mural thrombus are removed. Prosthesis is cut obliquely and anastomosis suturing starts with distal angle. Occluded at the prosthetic base jaws, aortic compressor is removed, restoring blood flow in the lower limb. Next stage is tunnel creating for jaws prosthesis conduction on hip. Ureters must remain over the prosthesis, jaw should be above the iliac arteries. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. Before anastomosis completion the testing jaws and all arteries bloodletting is performed. Receives: Procedure: Aorta femoral Bypass |
| hybrid intervention | Experimental | Iliac Arteries With Stenting and Plasty of the Common Femoral Artery Receives: Procedure: Hybrid Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment in the 30-day period: clinically significant bleeding, hematoma, infection of the prosthesis, infection of the postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment
Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire. Classification of bleeding will be used GUSTO (Severe or moderate)
Measured: 30 days
Evaluation of efficiency: primary patency, secondary patency success of procedures, length of hospital stay
If a damage confirmed by duplex is detected, repeat intervention is performed on the side of the examined segment
Measured: 30 days
Evaluation of efficiency: success of procedures
Technical feasibility of the procedure
Measured: 30 days
Secondary outcomes (5)
mortality
Measured: during the whole period of observation. Observation is 36 month after surgery
stroke
Measured: during the whole period of observation. Observation is 36 month after surgery
myocardial infarction
Measured: during the whole period of observation. Observation is 36 month after surgery
limb salvage
Measured: in the early postoperative period. Surveillance is 36 month after surgery
infection of the prosthesis
Measured: during the whole period of observation. Observation is 36 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2017
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atherosclerosis of the Peripheral ArteriesStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580084
- Sponsor's protocol ID
- NRICP111
- Status last verified
- May 2021
- First submitted
- 14 Oct 2015
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Starodubtsev V, Mitrofanov V, Ignatenko P, Gostev A, Preece R, Rabtsun A, Saaya S, Popova I, Karpenko A. Editor's Choice - Hybrid vs. Open Surgical Reconstruction for Iliofemoral Occlusive Disease: A Prospective Randomised Trial. Eur J Vasc Endovasc Surg. 2022 Apr;63(4):557-565. doi: 10.1016/j.ejvs.2022.02.002. Epub 2022 Feb 9.
PubMed 35283003
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Study of the Aorta-femoral Bypass and Hybrid Intervention and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery Effectiveness in Patients With the Iliac Segment and Femoral Artery Occlusive Disease (TASC C, D)
- ClinicalTrials.gov ID
- NCT02580084
- Acronym / sponsor ID
- NRICP111
- Keywords
- atherosclerosis of the peripheral arteries, Aorta-femoral Bypass, Hybrid Intervention, Iliac Arteries With Stenting and Plasty of the Common Femoral Artery, plastic arteries with lesions of the common femoral artery and deep femoral artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 20 Oct 2015 (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.
Currently, according to the TASC II consensus document (2007) and the Russian guidelines for limb ischemia treatment (2010), aorta-iliac C and D type segment lesions the open surgery is suggested.
Detailed description
Currently, according to the TASC II consensus document (2007) and the Russian guidelines for limb ischemia treatment (2010), aorta-iliac C and D type segment lesions the open surgery is suggested.
According to different studies, 76% occlusive aorta-iliac article course patients indicate femoral-popliteal segment lesions. Due to the lack of inflow and outflow ways of correction needed for adequate limb revascularization surgery treatment of multistorey atherosclerotic lesions patients is still one of the most complex problems of vascular surgery. Perioperational mortality of critical limb ischemia patients reaches 5-10% in retrograde aorta-iliac segment reconstruction.
Due to its high efficiency hybrid operative invasion is one of the most perspective directions in reconstructive vascular surgery development (92-98% of the cases with the small number of post-operative complications).
Furthermore, hybrid surgery is possible with the critical iliac segment and femoral artery lesions, since stenting in the field of physiological bends (femoral artery) may lead to its breaking and artery thrombosis. Arterial segments blood flow reconstruction is possible with hybrid innervations meaning iliac segment stenting and common femoral artery patch.
All reports of iliac arteries stenosis percutaneous angioplasty indicate that the primary technical and clinical success rate exceeds 90%. The technical success of iliac arteries long occlusions recanalization reaches 80-85%. Improvement of endovascular equipment designed for the total occlusions treatment increases technical success of recanalization. The TASC II materials summarize the several large studies results which present the data on the operated segment artery patency at the level of 70-81% within 5-8 years of follow up. A large number of authors note the actuality of aortic-iliac type C and D segment lesions endovascular treatment recommendations revision according to the TASC II, together with hybrid technics implementation in this category of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aorta femoral bypass | Active comparator | Procedure: Aorta femoral BypassIt is sufficient to identify only the anterior-lateral aorta surface. After heparinization the aorta is clamped above and below the anastomosis. The aorta is dissected along the anterior wall, calcium portions or mural thrombus are removed. Prosthesis is cut obliquely and anastomosis suturing starts with distal angle. Occluded at the prosthetic base jaws, aortic compressor is removed, restoring blood flow in the lower limb. Next stage is tunnel creating for jaws prosthesis conduction on hip. Ureters must remain over the prosthesis, jaw should be above the iliac arteries. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. Before anastomosis completion the testing jaws and all arteries bloodletting is performed. |
| hybrid intervention | Experimental | Procedure: Hybrid InterventionIliac Arteries With Stenting and Plasty of the Common Femoral Artery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with occlusive lesions of C and D type iliac segment and steno-occlusive lesions of the common femoral artery, and with chronic lower limb ischemia (II-IV degree by Fontaine, 2-5 degree by Rutherford), age: 47-75 years old.
- Patients who consented to participate in this study
Key exclusion criteria (10 listed)
- Chronic heart failure of III-IV functional class by New York Heart Association classification.
- Patients who have suffered a stroke or myocardial infarction less than 3 months
- Significant Steno-occlusive lesion of the contralateral side
- Decompensated chronic "pulmonary" heart
- Aortoarteritis
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 |
|---|---|---|
| Hybrid InterventionThe puncture of the femoral artery general is executed and the introducer 7Fr is set. Further, the hydrophilic conductor executes a recanalization of the Vasa of iliac artery occlusion. if you cannot pass the occlusion retrograde is additional access to antegrade recanalization. Then using hydrophilic conductors, an iliac artery antegrade or retrograde recanalization of the Vasa is made. Femoral artery arteriotomy. Further execute a direct endarterectomy femoral artery and from the mouth of a hip artery. arteriotomy of the femoral artery is closed with a vascular patch use (synthetic or biological). Balloon angioplasty and stenting, iliac artery is done, the controlling angiography Closing maims. | Procedure or surgery | hybrid intervention |
| Aorta femoral BypassIt is sufficient to identify only the anterior-lateral aorta surface. After heparinization the aorta is clamped above and below the anastomosis. The aorta is dissected along the anterior wall, calcium portions or mural thrombus are removed. Prosthesis is cut obliquely and anastomosis suturing starts with distal angle. Occluded at the prosthetic base jaws, aortic compressor is removed, restoring blood flow in the lower limb. Next stage is tunnel creating for jaws prosthesis conduction on hip. Ureters must remain over the prosthesis, jaw should be above the iliac arteries. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. Before anastomosis completion the testing jaws and all arteries bloodletting is performed. | Procedure or surgery | aorta femoral bypass |
Primary outcome
Safety assessment in the 30-day period: clinically significant bleeding, hematoma, infection of the prosthesis, infection of the postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment
Time frame: 30 days
Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire. Classification of bleeding will be used GUSTO (Severe or moderate)
Evaluation of efficiency: primary patency, secondary patency success of procedures, length of hospital stay
Time frame: 30 days
If a damage confirmed by duplex is detected, repeat intervention is performed on the side of the examined segment
Evaluation of efficiency: success of procedures
Time frame: 30 days
Technical feasibility of the procedure
5 secondary outcomes
mortality
Time frame: during the whole period of observation. Observation is 36 month after surgery
stroke
Time frame: during the whole period of observation. Observation is 36 month after surgery
myocardial infarction
Time frame: during the whole period of observation. Observation is 36 month after surgery
limb salvage
Time frame: in the early postoperative period. Surveillance is 36 month after surgery
infection of the prosthesis
Time frame: during the whole period of observation. Observation is 36 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Derived from this study: PubMed 35283003Starodubtsev V, Mitrofanov V, Ignatenko P, Gostev A, Preece R, Rabtsun A, Saaya S, Popova I, Karpenko A. Editor's Choice - Hybrid vs. Open Surgical Reconstruction for Iliofemoral Occlusive Disease: A Prospective Randomised Trial. Eur J Vasc Endovasc Surg. 2022 Apr;63(4):557-565. doi: 10.1016/j.ejvs.2022.02.002. Epub 2022 Feb 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Intervention and Aorta femoral Bypass in people with Atherosclerosis of the Peripheral Arteries, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 10 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: finished, as of the sponsor's last update on 11 Oct 2021. 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety assessment in the 30-day period: clinically significant bleeding, hematoma, infection of the prosthesis, infection of the postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580084, which also lists 1 linked publication.
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 11 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.