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

NCT03040063 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-02-02

No results posted yet for this study

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.

Conditions

  • Aneurysm; Popliteal Artery
  • Limb Ischemia

Interventions

PROCEDURE

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

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.

Sponsors & Collaborators

  • Petr Varejka

    collaborator UNKNOWN

  • Charles University, Czech Republic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2018-08-01
Completion
2020-08-01

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03040063 on ClinicalTrials.gov