Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery

Popliteal Aneurysm Clinical Trial

— VAP-AURC  

Official title:

Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery: Multicenter Prospective Registry of the Research in Vascular Surgery University Association (AURC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03996889
• Other study ID #: VAP-AURC
• Status: Not yet recruiting
• Start date: September 2019
• Est. completion date: September 2022

Study information

• Verified date: July 2019
• Source: Hospices Civils de Lyon
• Contact: Nellie DELLA SCHIAVA, MD
• Phone: 4 72 11 76 76
• Email: dellaschiava.nellie[@]neuf.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This multicentric, prospective study will evaluate the medium-term outcomes of patients implanted with GORE VIABAHN® stent grafts for popliteal artery aneurysms in scheduled elective surgery with the registry of the Research in Vascular Surgery University Association (AURC)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years old at time of treatment

• symptomatic or asymptomatic popliteal artery aneurysm needing surgery

• scheduled elective surgery

Exclusion Criteria:

• life expectancy of <1 year

• thrombotic occlusion of popliteal artery

• intolerance to antiplatelet drugs (antiaggregants)

• known allergies to GORE VIABAHN® stent graft materials/composition

• emergency surgery

Related Conditions & MeSH terms

• Aneurysm
• Popliteal Aneurysm

Intervention

Device:
• Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery
The intervention can be performed under local anesthesia (LA), regional locus (ALR) or general anesthesia (AG) (data collected) by first approach: percutaneous or conventional. The data collected are: Number of GORE VIABAHN® stent used (length and diameter of each) Embolization of collaterals and other related actions Operative complications Intraoperative fibrinolysis Collar cover> 2 cm Lack of overlap in the "overlap zone" (nb: between 4 and 8 cm above the joint spacing) Arteriography in profile, kink

Locations

Country	Name	City	State
France	Hôpital pneumologique et cardiovasculaire Louis Pradel (HCL)	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major limb events	Composite criterion associating Target Lesion Revascularization (TLR) and Rate of major amputation.; An Echo-Doppler imaging examination will be performed and the following parameters and information should be collected: Permeability; Intra-stent restenosis; Systolic pressure index	2 years of follow-up