Atherosclerosis of the Peripheral ArteriesTASC CDNCT03315884
Pilot Randomized Clinical Study of the Iliac Arteries and Common Femoral Artery With Stenting and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery
A study testing Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA) and Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch in people with Atherosclerosis of the Peripheral Arteries, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type D lesions. Read more about this study
- Who is it for?
- Ages 47 to 75 years
- Conditions the study is for
- Atherosclerosis of the Peripheral Arteries
- What is being tested?
- Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA) and Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2017to Dec 2020
- 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 47 to 75 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 CFA lesion, and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 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 (NYHA) classification.
- Decompensated chronic "pulmonary" heart
- Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min);
- Polyvalent drug allergy
- Cancer in the terminal stage with a life expectancy less than 6 months;
- Acute ischemic
- 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: Pilot Randomized Clinical Study of the Iliac Arteries and Common Femoral Artery With Stenting Supera and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery Effectiveness in Patients With the Iliac and CFA Segment Occlusive or Stenosis Disease (TASC C, D)
According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type D lesions.
Read the detailed description
According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type D lesions. Patients with type C lesions can be managed by either stenting or bypass surgery. Despite the fact that aorta-femoral reconstructions long-term results are better than the diffuse aorta-iliac lesions endovascular treatment results, the surgery risk is significantly higher than the endovascular surgery risk regarding criteria of mortality, complications, and return to normal activity.
All reports of iliac arteries stenosis percutaneous angioplasty indicate that the primary technical and clinical success rate exceeds 90%. The figure reaches 100% in the case of local lesions. 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.
- Being tested
- Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA), Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch
- Keywords
- TASC C, D, CFA, Supera, iliac arteries, common femoral artery, plasty of the common femoral artery, stenting Supera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)Procedure or surgery
Also called Endovascular intervention
Retrograde femoral access. Brachial access. Standard endovascular access is performed under local anesthesia and affected arterial segment is visualized. Stenosis or artery occlusion is passed with hydrophilic guide. In case of occlusion transluminal or subintimal (often "mixed") artery recanalization is performed. To maximize the preservation of the affected artery initial patency, occlusion recanalization is performed by ante-and retrograde accesses. Then stenosis or occlusion predilation is performed with balloon catheter (balloon catheter diameter is smaller than the affected artery diameter for 1-2 mm). After control angiography stent is installed in the aorta-iliac area throughout the lesion (lesion diameter corresponds to the stenotic arteries diameter). In aorta-iliac zone balloon-expandable and self-expandable stents are used.
Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patchProcedure or surgery
Also called Hybrid Intervention
Standard access to the CFA is performed. Outflow ways and CFA capability for reconstruction are determined. The puncture of the general CFA (retrograde) is performed and the introducer 7Fr. is set. Recanalization of iliac artery occlusion. It is necessary to cross the iliac occlusion in a retrograde fashion first and secure aortic inflow before making the arteriotomy. An ipsilateral, a contralateral and a brachial approaches are used depending on the clinical situation. If the retrograde access to the aorta failed, you use the antegrade crossing of the iliac occlusion with no intention to reenter the lumen in the CFA. After the recanalization and balloon angioplasty of iliac artery we completed the procedure with endarterectomy of CFA, patch closure and iliac stenting. The preference is to perform endarterectomy and patch before iliac stenting because it can be difficult to access the true lumen in a difficult CFA lesion. Controlling angiography were performed. Closing approach.
| Study group | Role | What they receive |
|---|---|---|
| Iliac segment recanalization and stenting Iliac segment CFA | Experimental | Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA) Receives: Procedure: Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch |
| Iliac segment recanalization, stenting and plastic CFA patch | Active comparator | Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch Receives: Procedure: Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency of the operated segment
during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities
Measured: during the whole period of observation. Observation is 24 month after surgery
Secondary outcomes (8)
Secondary patency of the operated artery restenosis
during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities
Measured: during the whole period of observation. Observation is 24 month after surgery
reocclusion
during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities
Measured: during the whole period of observation. Observation is 24 month after surgery
postoperative bleeding
assessment of bleeding within 30 days after surgery. The identification of bleeding with physical examination and ultrasound.Considered bleeding requiring surgical intervention
Measured: in the early postoperative period. Surveillance is 30 days after surgery
hematoma
Measured: in the early postoperative period. Surveillance is 30 days after surgery
myocardial infarction
Measured: during the whole period of observation. Observation is 24 month after surgery
mortality
Measured: during the whole period of observation. Observation is 24 month after surgery
limb amputation
Measured: during the whole period of observation. Observation is 24 month after surgery
infection
Measured: during the whole period of observation. Observation is 24 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 2017
- Study start1 Dec 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Collaborators
- Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315884
- Sponsor's protocol ID
- NRICP112
- Acronym
- TASC CD
- Status last verified
- May 2020
- First submitted
- 17 Oct 2017
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saaya SB, Khomushku DV, Gostev AA, Cheban AV, Osipova OS, Ignatenko PV, Starodubtsev VB, Karpenko AA. [Endovascular versus hybrid interventions for steno-occlusive lesions of the iliofemoral segment (a pilot prospective randomized trial)]. Angiol Sosud Khir. 2025 Sep 30;31(3):102-110. doi: 10.33029/1027-6661-2025-31-3-102-110. Russian.
PubMed 41805484
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Clinical Study of the Iliac Arteries and Common Femoral Artery With Stenting Supera and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery Effectiveness in Patients With the Iliac and CFA Segment Occlusive or Stenosis Disease (TASC C, D)
- ClinicalTrials.gov ID
- NCT03315884
- Acronym / sponsor ID
- TASC CD / NRICP112
- Keywords
- TASC C, D, CFA, Supera, iliac arteries, common femoral artery, plasty of the common femoral artery, stenting Supera
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Collaborators
- Abbott
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Oct 2017 (actual)
- 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.
According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type D lesions.
Detailed description
According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), reconstructive surgery is preferred for type D lesions. Patients with type C lesions can be managed by either stenting or bypass surgery. Despite the fact that aorta-femoral reconstructions long-term results are better than the diffuse aorta-iliac lesions endovascular treatment results, the surgery risk is significantly higher than the endovascular surgery risk regarding criteria of mortality, complications, and return to normal activity.
All reports of iliac arteries stenosis percutaneous angioplasty indicate that the primary technical and clinical success rate exceeds 90%. The figure reaches 100% in the case of local lesions. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iliac segment recanalization and stenting Iliac segment CFA | Experimental | Procedure: Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patchIliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA) |
| Iliac segment recanalization, stenting and plastic CFA patch | Active comparator | Procedure: Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch |
Who may qualify
- Ages
- 47 to 75 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 CFA lesion, and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford), age: 47-75 years old.
- Patients who consented to participate in this study.
Key exclusion criteria (8 listed)
- Chronic heart failure of III-IV functional class by New York Heart Association (NYHA) classification.
- Decompensated chronic "pulmonary" heart
- Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min);
- Polyvalent drug allergy
- Cancer in the terminal stage with a life expectancy less than 6 months;
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 |
|---|---|---|
| Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)Also: Endovascular interventionRetrograde femoral access. Brachial access. Standard endovascular access is performed under local anesthesia and affected arterial segment is visualized. Stenosis or artery occlusion is passed with hydrophilic guide. In case of occlusion transluminal or subintimal (often "mixed") artery recanalization is performed. To maximize the preservation of the affected artery initial patency, occlusion recanalization is performed by ante-and retrograde accesses. Then stenosis or occlusion predilation is performed with balloon catheter (balloon catheter diameter is smaller than the affected artery diameter for 1-2 mm). After control angiography stent is installed in the aorta-iliac area throughout the lesion (lesion diameter corresponds to the stenotic arteries diameter). In aorta-iliac zone balloon-expandable and self-expandable stents are used. | Procedure or surgery | Iliac segment recanalization, stenting and plastic CFA patch |
| Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patchAlso: Hybrid InterventionStandard access to the CFA is performed. Outflow ways and CFA capability for reconstruction are determined. The puncture of the general CFA (retrograde) is performed and the introducer 7Fr. is set. Recanalization of iliac artery occlusion. It is necessary to cross the iliac occlusion in a retrograde fashion first and secure aortic inflow before making the arteriotomy. An ipsilateral, a contralateral and a brachial approaches are used depending on the clinical situation. If the retrograde access to the aorta failed, you use the antegrade crossing of the iliac occlusion with no intention to reenter the lumen in the CFA. After the recanalization and balloon angioplasty of iliac artery we completed the procedure with endarterectomy of CFA, patch closure and iliac stenting. The preference is to perform endarterectomy and patch before iliac stenting because it can be difficult to access the true lumen in a difficult CFA lesion. Controlling angiography were performed. Closing approach. | Procedure or surgery | Iliac segment recanalization and stenting Iliac segment CFA |
Primary outcome
Primary patency of the operated segment
Time frame: during the whole period of observation. Observation is 24 month after surgery
during the whole period of observation. confirmation of patency of the arterial ultrasound of the operated segment. Confirmation patency of artery 24 months after surgery using Multislice computed tomography angiography of the lower extremities
8 secondary outcomes
Secondary patency of the operated artery restenosis
Time frame: during the whole period of observation. Observation is 24 month after surgery
reocclusion
Time frame: during the whole period of observation. Observation is 24 month after surgery
postoperative bleeding
Time frame: in the early postoperative period. Surveillance is 30 days after surgery
hematoma
Time frame: in the early postoperative period. Surveillance is 30 days after surgery
myocardial infarction
Time frame: during the whole period of observation. Observation is 24 month after surgery
mortality
Time frame: during the whole period of observation. Observation is 24 month after surgery
limb amputation
Time frame: during the whole period of observation. Observation is 24 month after surgery
infection
Time frame: during the whole period of observation. Observation is 24 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Derived from this study: PubMed 41805484Saaya SB, Khomushku DV, Gostev AA, Cheban AV, Osipova OS, Ignatenko PV, Starodubtsev VB, Karpenko AA. [Endovascular versus hybrid interventions for steno-occlusive lesions of the iliofemoral segment (a pilot prospective randomized trial)]. Angiol Sosud Khir. 2025 Sep 30;31(3):102-110. doi: 10.33029/1027-6661-2025-31-3-102-110. Russian.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA) and Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch 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 8 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 28 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vyacheslav Mitrofanov (+79139255543, v_mitrofanov@meshalkin.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency of the operated segment (time frame: during the whole period of observation. Observation is 24 month after surgery). 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 NCT03315884, 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 28 May 2020.