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Completed

NCT Number: NCT05296031

Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex

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

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Key information

Conditions

Vascular Diseases Cardiovascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions

Device

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

Device

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

Primary outcomes

  1. Freedom from TLR (Target Lesion Revascularization)

    Time frame: 6 months

    Fraction of study subjects without need for retreatment at treatment location

  2. Freedom from TLR (Target Lesion Revascularization)

    Time frame: 12 months

    Fraction of study subjects without need for retreatment at treatment location

  3. Freedom from TLR (Target Lesion Revascularization)

    Time frame: 24 months

    Fraction of study subjects without need for retreatment at treatment location

  4. Open (functioning and not stenosed) vascular reconstruction (Primary Patency)

    Time frame: 12months

    Functioning revascularization without adjunctive measures

  5. Open (functioning and not stenosed) vascular reconstruction (Primary Patency)

    Time frame: 24 months

    Functioning revascularization without adjunctive measures

  6. Event Free Survival

    Time frame: 24 months

    Alive without vascular events

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Registry information

Official study 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"

Important dates

Study start
2013
Primary completion
2017
Study completion
2019
First posted
Mar 25, 2022
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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