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

Limb Ischemia Clinical Trial

— EVAR-P  

Official title:

Complex Endovascular Approach to Treatment of Patients With Aneurysm of Popliteal Artery and Acute Limb Ischemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03040063
• Other study ID #: EVAR-P
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2017
• Last updated: January 31, 2017
• Start date: August 1, 2016
• Est. completion date: August 1, 2020

Study information

• Verified date: January 2017
• Source: Charles University, Czech Republic
• Contact: Jean Claude Lubanda, Ass.Prof., MD., Ph.D.
• Phone: 00420224962692
• Email: Jean-Claude.Lubanda[@]vfn.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm; Popliteal Artery
• Ischemia
• Limb Ischemia

Intervention

Procedure:
• Combined endovascular approach (EVAR)
puncture of SFA in orthograde position if possible DSA through 4F dilator, proof of occlusion wire test Heparin 70-80 IU/kg i.a. implantation of peripheral stent graft VIABAHN implantation of peripheral stent SUPERA into stent graft insertion of strait flush catheter for local thrombolysis administration of continuous local thrombolysis in the dose of 1 mg/hr., unfractionated heparin continuously (APTT 1,5-2x) according to the department standards control angiography in 12 hrs or earlier according to clinical status and symptoms repeated angiography in 24 hrs
• Standard optimal therapy (OPT)
puncture of SFA in orthograde position if possible DSA through 4F dilator, proof of occlusion wire test Unfractionated heparin 70-80 IU/kg i.a. insertion of strait flush catheter for local thrombolysis administration of continuous local thrombolysis in the dose of 1 mg/hr., unfractionated heparin continuously (APTTT 1,5-2x) control angiography in 12 hrs or according to clinical status and symptoms repeated angiography in24 hrs Final result review, vascular team consultation and indication for surgical or conservative management of popliteal artery aneurysm.

Locations

Country	Name	City	State
Czech Republic	Charles University in Prague	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Petr Varejka

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limb salvage in 12 months	Limba salvage in 12 months	12 Months
Primary	Patency of the popliteal artery in 12 months	Patency of the popliteal artery in 12 months	12 Months