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

Atherosclerosis of the Peripheral Arteries Clinical Trial

— TASC CD  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03315884
• Other study ID #: NRICP112
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Vyacheslav Mitrofanov
• Phone: +79139255543
• Email: v_mitrofanov[@]meshalkin.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 47 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis of the Peripheral Arteries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	NRICP	Novosibirsk

Sponsors (2)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation	Abbott

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	hematoma		in the early postoperative period. Surveillance is 30 days after surgery
Secondary	myocardial infarction		during the whole period of observation. Observation is 24 month after surgery
Secondary	mortality		during the whole period of observation. Observation is 24 month after surgery
Secondary	limb amputation		during the whole period of observation. Observation is 24 month after surgery
Secondary	infection		during the whole period of observation. Observation is 24 month after surgery