Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the AFB and Stenting of the Iliac Arteries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02209350
Recruitment Status : Recruiting
First Posted : August 5, 2014
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

Brief 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).

Condition or disease Intervention/treatment Phase
Aorta-iliac Segment Lesion (C,D Type by TASC II) Procedure: Aorta-femoral bypass Procedure: Recanalization and stenting of aorta-iliac segment Drug: Therapy: aspirin and clopidogrel Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1
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).
Procedure: Aorta-femoral bypass

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".


Drug: Therapy: aspirin and clopidogrel
prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).

Active Comparator: Group 2
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).
Procedure: Recanalization and stenting of aorta-iliac segment

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).


Drug: Therapy: aspirin and clopidogrel
prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).




Primary Outcome Measures :
  1. The primary composite endpoint (efficacy): primary patency, secondary patency [ Time Frame: 30 days ]
    If a damage confirmed by duplex is detected, repeat intervention is performed on the side of the examined segment. The physiological parameter and questionnaire will be used.

  2. success of the procedure [ Time Frame: 30 days ]
    Technical ability to perform the surgical intervention

  3. safeness: 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 [ Time Frame: 30 days ]
    Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire. Classification of bleeding will be used GUSTO (Severe or moderate)


Secondary Outcome Measures :
  1. mortality in the long-term postoperative period [ Time Frame: 3 years ]
  2. stroke in the remote postoperative period [ Time Frame: 3 years ]
  3. myocardial infarction in the remote postoperative period [ Time Frame: 3 years ]
  4. preservation of limb in the long-term postoperative period [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with occlusive lesions of C and D type iliac segment, 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 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
  • Patients with significant common femoral artery lesion
  • Patient refusal to participate or continue to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209350


Contacts
Layout table for location contacts
Contact: Andrey Karpenko, MD, PhD +79139504100 andreikarpenko@rambler.ru
Contact: Vladimir Starodubtsev, MD, PhD +79137262163 starodub@mail.ru

Locations
Layout table for location information
Russian Federation
Novosibirsk Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Vladimir Starodubtsev, MD, PhD    +79137262163    starodub@mail.ru   
Sub-Investigator: Pavel Ignatenko, MD         
Sub-Investigator: Dmitriy Zoloev, MD         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Layout table for investigator information
Principal Investigator: Andrey Karpenko, MD, PhD Novosibirsk Research Institute of Circulation Pathology

Layout table for additonal information
Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02209350     History of Changes
Other Study ID Numbers: TASC C,D
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: September 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents