Complex Endovascular Approach to Treatment of Patients With Aneurysm of Popliteal Artery

Not Applicable

• Conditions: Limb Ischemia; Aneurysm; Popliteal Artery
• Interventions: Procedure: Standard optimal therapy (OPT); Procedure: Combined endovascular approach (EVAR)

• Registration Number: NCT03040063
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

Use of endovascular techniques - implantation of a peripheral stent graft and a peripheral flexible stent to isolate the sac of the popliteal artery aneurysm from the circulation and subsequent topical application of a thrombolytic (rtPA) to restore patency of the lower leg blood stream - will lead to a comparable or better outcome in treatment of patients with the popliteal artery aneurysm and acute critical limb ischaemia, compared to currently prevailing use of surgical treatment.

Detailed Description

The 2nd Medical Department admits patients with acute arterial occlusion at the stage of critical limb ischaemia. The poorest prognosis considering preservation of the limb is shown by the patients who exhibit symptoms of ischaemia due to affected popliteal artery and arteries of the shank in the the popliteal artery aneurysm. On the other hand, diagnosis of this condition is prompt and easy (general ultrasound scan below the knee). Patients with the popliteal artery aneurysm, confirmed by ultrasound investigation, and concurrent signs and symptoms of acute critical ischaemia will be indicated for catheterization intervention at our unit, which will confirm morphological compatibility with endovascular occlusion of the aneurysm sac through implantation of a peripheral stent graft, supported by implantation of a peripheral flexible stent, and at the same time insertion of a thrombolytic catheter into the implanted stent graft for local thrombolysis of tibial arteries if required by the current situation. The patient will be hospitalized at the angiology intensive care unit of the 2nd Medical Department, where local intra-arterial thrombolytic therapy will be performed according to the standard protocol. After completion of the proper endovascular treatment, the patients will be transferred to combined peroral anticoagulation and antiaggregation treatment, and all of them will have an ultrasound scan below the knee, with the readings archived for the purpose of further comparison and monitoring. Subsequently, the patients will be monitored in the outpatient regime after 6 weeks, 3, 6 and 12 months. At each visit, clinical examination will be done including establishment of ABI/TBI values and ultrasound investigation of the region below the knee.

Study Timeline

• Study Start: 2016-08-01
• Status Verified: 2017-01
• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-01-31
• Last Update Submitted: 2017-01-31
• Study First Posted: 2017-02-02
• Last Update Posted: 2017-02-02
• Primary Completion: 2018-08-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Signed informed consent form for the patient's participation in the study.
2. Acute critical limb ischaemia with impairment of the extremity at stage I, IIa, IIb according to SVS classification.
3. A popliteal artery aneurysm, confirmed by ultrasound scanning, which on catheterization examination meets the criteria for isolation of the aneurysm sac by implantation of a peripheral stent graft, supported by insertion of a peripheral flexible stent.
4. Absence of any contraindication for local thrombolytic therapy.
5. An anatomic finding through angiographic investigation that is suitable for endovascular therapy.

Exclusion Criteria

1. Active bleeding or contraindication for local thrombolysis.
2. Life expectance < 1 yr
3. Relevant stenotic defects of valves.
4. Myocardial infarction or unstable angina pectoris in past 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard optimal therapy (OPT)	Standard optimal therapy (OPT)	standard therapy of popliteal artery aneurysm using thrombolysis and surgery
Combined endovascular approach	Combined endovascular approach (EVAR)	Combined endovascular approach using covered stent and flexible stent in the popliteal artery

Primary Outcome Measures

Name	Time	Method
Patency of the popliteal artery in 12 months	12 Months	Patency of the popliteal artery in 12 months
Limb salvage in 12 months	12 Months	Limba salvage in 12 months

Trial Locations

Locations (1)

Charles University in Prague; 🇨🇿 Prague, Czech Republic