Complex Endovascular Approach to Treatment of Patients With Aneurysm of Popliteal Artery (EVAR-P)
Primary Purpose
Aneurysm; Popliteal Artery, Limb Ischemia
Status
Unknown status
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Combined endovascular approach (EVAR)
Standard optimal therapy (OPT)
Sponsored by
About this trial
This is an interventional treatment trial for Aneurysm; Popliteal Artery focused on measuring aneurysm, poplietl artery, acute limb ischemia
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent form for the patient's participation in the study.
- Acute critical limb ischaemia with impairment of the extremity at stage I, IIa, IIb according to SVS classification.
- 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.
- Absence of any contraindication for local thrombolytic therapy.
- An anatomic finding through angiographic investigation that is suitable for endovascular therapy.
Exclusion Criteria:
- Active bleeding or contraindication for local thrombolysis.
- Life expectance < 1 yr
- Relevant stenotic defects of valves.
- Myocardial infarction or unstable angina pectoris in past 3 months.
Sites / Locations
- Charles University in PragueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Combined endovascular approach
Standard optimal therapy (OPT)
Arm Description
Combined endovascular approach using covered stent and flexible stent in the popliteal artery
standard therapy of popliteal artery aneurysm using thrombolysis and surgery
Outcomes
Primary Outcome Measures
Limb salvage in 12 months
Limba salvage in 12 months
Patency of the popliteal artery in 12 months
Patency of the popliteal artery in 12 months
Secondary Outcome Measures
Full Information
NCT ID
NCT03040063
First Posted
January 31, 2017
Last Updated
January 31, 2017
Sponsor
Charles University, Czech Republic
Collaborators
Petr Varejka
1. Study Identification
Unique Protocol Identification Number
NCT03040063
Brief Title
Complex Endovascular Approach to Treatment of Patients With Aneurysm of Popliteal Artery
Acronym
EVAR-P
Official Title
Complex Endovascular Approach to Treatment of Patients With Aneurysm of Popliteal Artery and Acute Limb Ischemia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
Collaborators
Petr Varejka
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm; Popliteal Artery, Limb Ischemia
Keywords
aneurysm, poplietl artery, acute limb ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined endovascular approach
Arm Type
Experimental
Arm Description
Combined endovascular approach using covered stent and flexible stent in the popliteal artery
Arm Title
Standard optimal therapy (OPT)
Arm Type
Experimental
Arm Description
standard therapy of popliteal artery aneurysm using thrombolysis and surgery
Intervention Type
Procedure
Intervention Name(s)
Combined endovascular approach (EVAR)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Standard optimal therapy (OPT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Limb salvage in 12 months
Description
Limba salvage in 12 months
Time Frame
12 Months
Title
Patency of the popliteal artery in 12 months
Description
Patency of the popliteal artery in 12 months
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent form for the patient's participation in the study.
Acute critical limb ischaemia with impairment of the extremity at stage I, IIa, IIb according to SVS classification.
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.
Absence of any contraindication for local thrombolytic therapy.
An anatomic finding through angiographic investigation that is suitable for endovascular therapy.
Exclusion Criteria:
Active bleeding or contraindication for local thrombolysis.
Life expectance < 1 yr
Relevant stenotic defects of valves.
Myocardial infarction or unstable angina pectoris in past 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Claude Lubanda, Ass.Prof., MD., Ph.D.
Phone
00420224962692
Email
Jean-Claude.Lubanda@vfn.cz
Facility Information:
Facility Name
Charles University in Prague
City
Prague
ZIP/Postal Code
12808
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Claude Lubanda, Ass.Prof.MD
Phone
+420224962692
Email
Jean-Claude.Lubanda@vfn.cz
First Name & Middle Initial & Last Name & Degree
Martina Striteska, Mgr.
Phone
+224962605
Email
Martina.Striteska@vfn.cz
First Name & Middle Initial & Last Name & Degree
Jean-Claude Lubanda, Ass.Prof.MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Complex Endovascular Approach to Treatment of Patients With Aneurysm of Popliteal Artery
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