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
TASC CD
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2017
CompletedFirst Posted
Study publicly available on registry
October 20, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMay 28, 2020
May 1, 2020
3 years
October 17, 2017
May 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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. Observation is 24 month after surgery
reocclusion
during the whole period of observation. Observation is 24 month after surgery
postoperative bleeding
in the early postoperative period. Surveillance is 30 days after surgery
hematoma
in the early postoperative period. Surveillance is 30 days after surgery
myocardial infarction
during the whole period of observation. Observation is 24 month after surgery
- +3 more secondary outcomes
Study Arms (2)
Iliac segment recanalization and stenting Iliac segment CFA
EXPERIMENTALIliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)
Iliac segment recanalization, stenting and plastic CFA patch
ACTIVE COMPARATORIliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meshalkin Research Institute of Pathology of Circulationlead
- Abbottcollaborator
Study Sites (1)
NRICP
Novosibirsk, 630055, Russia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2017
First Posted
October 20, 2017
Study Start
December 1, 2017
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
May 28, 2020
Record last verified: 2020-05