Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex

Vascular Diseases Clinical Trial

Official title:

Randomized Trial Comparing Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex in Critical Limb Ischemia and Treatment of Lesions in Femoral and Popliteal Arteries"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05296031
• Other study ID #: TF2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2013
• Est. completion date: August 31, 2019

Study information

• Verified date: August 2023
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

Critical limb ischemia RC 4-6

Lesions in superficial femoral artery and popliteal artery (p1 -p2)

Target vessel 4-8mm

At least I 1 vessel runoff to the foot

Age >18 years

Exclusion Criteria:

Pregnancy

Patient disapproval

Age <18 years

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Device:
• Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions
Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
• Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions
Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from TLR (Target Lesion Revascularization)	Fraction of study subjects without need for retreatment at treatment location	6 months
Primary	Freedom from TLR (Target Lesion Revascularization)	Fraction of study subjects without need for retreatment at treatment location	12 months
Primary	Freedom from TLR (Target Lesion Revascularization)	Fraction of study subjects without need for retreatment at treatment location	24 months
Primary	Open (functioning and not stenosed) vascular reconstruction (Primary Patency)	Functioning revascularization without adjunctive measures	12months
Primary	Open (functioning and not stenosed) vascular reconstruction (Primary Patency)	Functioning revascularization without adjunctive measures	24 months
Primary	Event Free Survival	Alive without vascular events	24 months