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)

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.

Study Overview

• Status: Unknown
• Conditions: Atherosclerosis of the Peripheral Arteries
• Intervention / Treatment: Procedure: Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch; Procedure: Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vyacheslav Mitrofanov; Phone Number: +79139255543; Email: v_mitrofanov@meshalkin.ru

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Recruiting
    • NRICP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 47 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iliac segment recanalization and stenting Iliac segment CFA; Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)	Procedure: Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch; 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.; Other Names: Hybrid Intervention
Active Comparator: Iliac segment recanalization, stenting and plastic CFA patch; Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch	Procedure: Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA); 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.; Other Names: Endovascular intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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
mortality		during the whole period of observation. Observation is 24 month after surgery
limb amputation		during the whole period of observation. Observation is 24 month after surgery
infection		during the whole period of observation. Observation is 24 month after surgery

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Collaborators: Abbott

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: common femoral artery; TASC C, D; CFA; Supera; iliac arteries; plasty of the common femoral artery; stenting Supera
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: NRICP112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No