NCT03040063

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

January 31, 2017

Last Update Submit

January 31, 2017

Conditions

Aneurysm; Popliteal ArteryLimb Ischemia

Keywords

aneurysm, poplietl artery, acute limb ischemia

Outcome Measures

Primary Outcomes (2)

  • Limb salvage in 12 months

    Limba salvage in 12 months

    12 Months

  • Patency of the popliteal artery in 12 months

    Patency of the popliteal artery in 12 months

    12 Months

Study Arms (2)

Combined endovascular approach

EXPERIMENTAL

Combined endovascular approach using covered stent and flexible stent in the popliteal artery

Procedure: Combined endovascular approach (EVAR)

Standard optimal therapy (OPT)

EXPERIMENTAL

standard therapy of popliteal artery aneurysm using thrombolysis and surgery

Procedure: Standard optimal therapy (OPT)

Interventions

Combined endovascular approach (EVAR)PROCEDURE

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

Combined endovascular approach
Standard optimal therapy (OPT)PROCEDURE

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.

Standard optimal therapy (OPT)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles University in Prague

Prague, 12808, Czechia

RECRUITING

MeSH Terms

Conditions

Popliteal Artery AneurysmAneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Jean Claude Lubanda, Ass.Prof., MD., Ph.D.

CONTACT

00420224962692Jean-Claude.Lubanda@vfn.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.prof. MD, Ph.D.

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 2, 2017

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2020

Last Updated

February 2, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)