Aneurysm; Popliteal ArteryEVAR-PNCT03040063
Complex Endovascular Approach to Treatment of Patients With Aneurysm of Popliteal Artery
A study testing Combined endovascular approach (EVAR) and Standard optimal therapy (OPT) in people with Aneurysm; Popliteal Artery and Limb Ischemia, run by Charles University, Czech Republic at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aneurysm; Popliteal Artery, Limb Ischemia
- What is being tested?
- Combined endovascular approach (EVAR) and Standard optimal therapy (OPT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Aug 2016to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Charles University in Prague
Prague, 12808
Jean Claude Lubanda, Ass.Prof.MD, +420224962692, Jean-Claude.Lubanda@vfn.cz
Martina Striteska, Mgr., +224962605, Martina.Striteska@vfn.cz
About this study
Official title: Complex Endovascular Approach to Treatment of Patients With Aneurysm of Popliteal Artery and Acute Limb Ischemia
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.
Read the 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.
- Conditions
- Aneurysm; Popliteal Artery, Limb Ischemia
- Being tested
- Combined endovascular approach (EVAR), Standard optimal therapy (OPT)
- Keywords
- aneurysm, poplietl artery, acute limb ischemia
- Medical subject headings
- Popliteal Artery Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined endovascular approach (EVAR)Procedure or surgery
- 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)Procedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Combined endovascular approach | Experimental | Combined endovascular approach using covered stent and flexible stent in the popliteal artery Receives: Procedure: Combined endovascular approach (EVAR) |
| Standard optimal therapy (OPT) | Experimental | standard therapy of popliteal artery aneurysm using thrombolysis and surgery Receives: Procedure: Standard optimal therapy (OPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb salvage in 12 months
Limba salvage in 12 months
Measured: 12 Months
Patency of the popliteal artery in 12 months
Patency of the popliteal artery in 12 months
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Aug 2016
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm; Popliteal ArteryStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Petr Varejka
- Responsible party
- Principal investigator, Ass. prof. Jean-Claude M. Lubanda, MD, Ph.D, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040063
- Sponsor's protocol ID
- EVAR-P
- Acronym
- EVAR-P
- Status last verified
- Jan 2017
- First submitted
- 31 Jan 2017
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Endovascular Approach to Treatment of Patients With Aneurysm of Popliteal Artery and Acute Limb Ischemia
- ClinicalTrials.gov ID
- NCT03040063
- Acronym / sponsor ID
- EVAR-P / EVAR-P
- Conditions
- Aneurysm; Popliteal Artery, Limb Ischemia
- Keywords
- aneurysm, poplietl artery, acute limb ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Petr Varejka
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined endovascular approach | Experimental | Procedure: Combined endovascular approach (EVAR)Combined endovascular approach using covered stent and flexible stent in the popliteal artery |
| Standard optimal therapy (OPT) | Experimental | Procedure: Standard optimal therapy (OPT)standard therapy of popliteal artery aneurysm using thrombolysis and surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined endovascular approach (EVAR)1. puncture of SFA in orthograde position if possible 2. DSA through 4F dilator, proof of occlusion 3. wire test 4. Heparin 70-80 IU/kg i.a. 5. implantation of peripheral stent graft VIABAHN 6. implantation of peripheral stent SUPERA into stent graft 7. insertion of strait flush catheter for local thrombolysis 8. administration of continuous local thrombolysis in the dose of 1 mg/hr., unfractionated heparin continuously (APTT 1,5-2x) according to the department standards 9. control angiography in 12 hrs or earlier according to clinical status and symptoms 10. repeated angiography in 24 hrs | Procedure or surgery | Combined endovascular approach |
| Standard optimal therapy (OPT)1. puncture of SFA in orthograde position if possible 2. DSA through 4F dilator, proof of occlusion 3. wire test 4. Unfractionated heparin 70-80 IU/kg i.a. 5. insertion of strait flush catheter for local thrombolysis 6. administration of continuous local thrombolysis in the dose of 1 mg/hr., unfractionated heparin continuously (APTTT 1,5-2x) 7. control angiography in 12 hrs or according to clinical status and symptoms 8. repeated angiography in24 hrs 9. Final result review, vascular team consultation and indication for surgical or conservative management of popliteal artery aneurysm. | Procedure or surgery | Standard optimal therapy (OPT) |
Primary outcome
Limb salvage in 12 months
Time frame: 12 Months
Limba salvage in 12 months
Patency of the popliteal artery in 12 months
Time frame: 12 Months
Patency of the popliteal artery in 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined endovascular approach (EVAR) and Standard optimal therapy (OPT) in people with Aneurysm; Popliteal Artery and Limb Ischemia, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Claude Lubanda, Ass.Prof., MD., Ph.D. (00420224962692, Jean-Claude.Lubanda@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb salvage in 12 months (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.