Aorta-iliac Segment Lesion (C,D Type by TASC II)Phase 1NCT02209350

Study of the AFB and Stenting of the Iliac Arteries

A Phase 1 study testing Aorta-femoral bypass, Recanalization and stenting of aorta-iliac segment and Therapy: aspirin and clopidogrel in people with Aorta-iliac Segment Lesion (C,D Type by TASC II), run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study is to compare effectiveness and long-term results of aorta-femoral reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC C,D). Read more about this study

Who is it for?: Ages 45 to 75 years
Conditions the study is for: Aorta-iliac Segment Lesion (C,D Type by TASC II)
What is being tested?: Aorta-femoral bypass, Recanalization and stenting of aorta-iliac segment and Therapy: aspirin and clopidogrel
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: 2 Aug 2015to 2 Nov 2020
Phase: Phase 1
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 45 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with unilateral steno-occlusive iliac lesions (TASC types C, D) and with chronic lower limb ischemia
Rutherford classification category 3-5 chronic limb ischemia,
age: 45-75 years old.
Patients who consented to participate in this study.

Who cannot join

Aortic thrombosis, concomitant abdominal aortic or iliac aneurysms, acute limb ischemia or vasculitis;
Flush occlusion of the common iliac artery;
Ipsilateral common femoral arteries steno-occlusive disease (occlusion or stenosis >50%);
Ipsilateral profunda femoris artery steno-occlusive disease (occlusion or stenosis >50%);
Refusal to participate in the study;
Stroke or myocardial infarction within the past 3 months;

Show all 12Show fewer

Ischemic heart disease with New York Heart Association functional class IV;
Malignant tumor with an estimated life span of under 6 months;
Previous ipsilateral or contralateral surgery (bypass, hybrid or stenting);
Hepatic or renal insufficiency (bilirubin> 35 mmol/l, glomerular filtration rate <60 ml/min/1.73 m2);
Severe calcification of the aorta and iliac arteries intolerant to balloon angioplasty (as determined by the Peripheral Arterial Calcification Scoring System on computed tomography angiography as interpreted by a vascular radiologist):12
unilateral calcification ≥ 5cm (Grade 2), bilateral calcification ≥ 5cm (Grade 4) or circumferential calcification , defined as 270°-360° around the circumference of aorta and/or iliac arteries.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Novosibirsk Research Institute of Circulation Pathology
Novosibirsk, 630055

Other trials in Russia

About this study

Official title: Prospective Randomized Clinical Study of the Aorto-femoral Bypass and the Iliac Arteries With Stenting Recanalization Effectiveness in Patients With the Iliac Segment Occlusive Disease

The aim of the study is to compare effectiveness and long-term results of aorta-femoral reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC C,D).

Conditions: Aorta-iliac Segment Lesion (C,D Type by TASC II)
Being tested: Aorta-femoral bypass, Recanalization and stenting of aorta-iliac segment, Therapy: aspirin and clopidogrel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aorta-femoral bypassProcedure or surgery
Access to the femoral artery is performed through a lateral incision from the inguinal ligament. Operations technique on the abdominal aorta.
Aorta-femoral bypass. Proximal anastomosis between the prosthesis and aorta is applied in the sort of "end-to-side" in the reconstruction by shunting.
After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. In a case of preserved antegrade blood flow the femoral artery anastomosis applied in the sort of "end-to-side". If antegrade flow is absent, anastomosis is formed in the sort of "end to end".
Recanalization and stenting of aorta-iliac segmentProcedure or surgery
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).
Therapy: aspirin and clopidogrelDrug
prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).

Study groups in NCT02209350
Study group	Role	What they receive
Group 1	Active comparator	Operations technique on the abdominal aorta. Aorta-femoral bypass. Medication: after surgery all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily). Receives: Procedure: Aorta-femoral bypass; Drug: Therapy: aspirin and clopidogrel
Group 2	Active comparator	Standard endovascular treatment (stenting) in patients with the iliac segment occlusive disease. Medication: after stenting all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily). Receives: Procedure: Recanalization and stenting of aorta-iliac segment; Drug: Therapy: aspirin and clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

Technical success
Successful implantation of all devices without the need for conversion and with residual stenosis less than 30%
Measured: 1 day
30-day complication rate
clinically significant bleeding, hematoma, infection of the prosthesis, infection of postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment, distal embolism
Measured: 30 days
30-day primary patency rates
during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment.
Measured: 30 days
30-day secondary patency rates
during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment after reintervention due to thrombosis
Measured: 30-day

Secondary outcomes (5)

Major adverse cardiovascular event (MACE)
composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Measured: 36 months
Limb salvage
preservation of a functional foot, eliminating the necessity for major amputation
Measured: 36 months
Amputation-free survival
freedom from major limb amputation or death by any cause
Measured: 36 months
Primary patency rates
no occlusion or significant flow-limiting stenosis in the treated segment
Measured: 36 months
Secondary patency rates
no occlusion or flow-limiting stenosis following at least one re-intervention aimed at restoring patency, in addition to all instances of primary patency
Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 20152 Nov 2020

First posted5 Aug 2014 (estimated)
Study start2 Aug 2015
Primary completion1 Nov 2020
Study completion2 Nov 2020

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 Aorta-iliac Segment Lesion (C,D Type by TASC II)Studies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02209350
Sponsor's protocol ID: TASC C,D
Status last verified: Jan 2025
First submitted: 30 Jul 2014
Last updated: 15 Jan 2025
Results posted: No
Data monitoring committee: Yes

Publications

Oganisyan SA, Saaya SB, Fattuloeva SS, Gostev AA, Cheban AV, Rabtsun AA, Bugurov SV, Osipova OS, Ignatenko PV, Starodubtsev VB, Mitrofanov VO, Karpenko AA. [Short- and medium-term results of open and endovascular treatment of steno-occlusive lesions of the iliac segment (TASC II C, D) in a randomized clinical trial]. Angiol Sosud Khir. 2023 Mar 30;29(1):79-88. doi: 10.33029/1027-6661-2023-29-1-79-88. Russian.
PubMed 41776867

Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Clinical Study of the Aorto-femoral Bypass and the Iliac Arteries With Stenting Recanalization Effectiveness in Patients With the Iliac Segment Occlusive Disease
ClinicalTrials.gov ID: NCT02209350
Acronym / sponsor ID: TASC C,D
Conditions: Aorta-iliac Segment Lesion (C,D Type by TASC II)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: Meshalkin Research Institute of Pathology of CirculationResearch network
Study start: 2 Aug 2015 (actual)
Primary completion: 1 Nov 2020 (actual)
Study completion: 2 Nov 2020 (actual)
First posted: 5 Aug 2014 (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.

The aim of the study is to compare effectiveness and long-term results of aorta-femoral reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC C,D).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Active comparator	Procedure: Aorta-femoral bypass, Drug: Therapy: aspirin and clopidogrelOperations technique on the abdominal aorta. Aorta-femoral bypass. Medication: after surgery all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).
Group 2	Active comparator	Procedure: Recanalization and stenting of aorta-iliac segment, Drug: Therapy: aspirin and clopidogrelStandard endovascular treatment (stenting) in patients with the iliac segment occlusive disease. Medication: after stenting all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).

Who may qualify

Ages: 45 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients with unilateral steno-occlusive iliac lesions (TASC types C, D) and with chronic lower limb ischemia
Rutherford classification category 3-5 chronic limb ischemia,
age: 45-75 years old.
Patients who consented to participate in this study.

Key exclusion criteria (12 listed)

Aortic thrombosis, concomitant abdominal aortic or iliac aneurysms, acute limb ischemia or vasculitis;
Flush occlusion of the common iliac artery;
Ipsilateral common femoral arteries steno-occlusive disease (occlusion or stenosis >50%);
Ipsilateral profunda femoris artery steno-occlusive disease (occlusion or stenosis >50%);
Refusal to participate in the study;

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
Aorta-femoral bypassAccess to the femoral artery is performed through a lateral incision from the inguinal ligament. Operations technique on the abdominal aorta. Aorta-femoral bypass. Proximal anastomosis between the prosthesis and aorta is applied in the sort of "end-to-side" in the reconstruction by shunting. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. In a case of preserved antegrade blood flow the femoral artery anastomosis applied in the sort of "end-to-side". If antegrade flow is absent, anastomosis is formed in the sort of "end to end".	Procedure or surgery	Group 1
Recanalization and stenting of aorta-iliac segmentStandard 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).	Procedure or surgery	Group 2
Therapy: aspirin and clopidogrelprescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).	Drug	Group 1, Group 2

Primary outcome

Technical success
Time frame: 1 day
Successful implantation of all devices without the need for conversion and with residual stenosis less than 30%
30-day complication rate
Time frame: 30 days
clinically significant bleeding, hematoma, infection of the prosthesis, infection of postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment, distal embolism
30-day primary patency rates
Time frame: 30 days
during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment.
30-day secondary patency rates
Time frame: 30-day
during the whole 30 days from the date of intervention. confirmation of patency of the arterial ultrasound of the operated segment after reintervention due to thrombosis

5 secondary outcomes

Major adverse cardiovascular event (MACE)
Time frame: 36 months
Limb salvage
Time frame: 36 months
Amputation-free survival
Time frame: 36 months
Primary patency rates
Time frame: 36 months
Secondary patency rates
Time frame: 36 months

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 15 Jan 2025.
Derived from this study: PubMed 41776867Oganisyan SA, Saaya SB, Fattuloeva SS, Gostev AA, Cheban AV, Rabtsun AA, Bugurov SV, Osipova OS, Ignatenko PV, Starodubtsev VB, Mitrofanov VO, Karpenko AA. [Short- and medium-term results of open and endovascular treatment of steno-occlusive lesions of the iliac segment (TASC II C, D) in a randomized clinical trial]. Angiol Sosud Khir. 2023 Mar 30;29(1):79-88. doi: 10.33029/1027-6661-2023-29-1-79-88. Russian.

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.

Andrey Karpenko, MD, PhD principal investigator

Novosibirsk Research Institute of Circulation Pathology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 12 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 15 Jan 2025. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Technical success (time frame: 1 day). The study lists 4 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 NCT02209350, 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 15 Jan 2025.