Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex

NCT05296031 | Completed

• 1 other identifier: TF2
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (6)

• Freedom from TLR (Target Lesion Revascularization)

  Fraction of study subjects without need for retreatment at treatment location

  6 months

• Freedom from TLR (Target Lesion Revascularization)

  Fraction of study subjects without need for retreatment at treatment location

  12 months

• Freedom from TLR (Target Lesion Revascularization)

  Fraction of study subjects without need for retreatment at treatment location

  24 months

• Open (functioning and not stenosed) vascular reconstruction (Primary Patency)

  Functioning revascularization without adjunctive measures

  12months

• Open (functioning and not stenosed) vascular reconstruction (Primary Patency)

  Functioning revascularization without adjunctive measures

  24 months

• Event Free Survival

  Alive without vascular events

  24 months

Study Arms (2)

Drug Eluting Stent (DES)

ACTIVE COMPARATOR

Drug Eluting Stent (DES). Zilver PTX.

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

Bare Metal Stent (BMS)

PLACEBO COMPARATOR

Bare Metal Stent (BMS). Zilver Flex

Device: Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions

Interventions

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

Drug Eluting Stent (DES)

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

Bare Metal Stent (BMS)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Patient disapproval
• Age \<18 years

Sponsors & Collaborators

• Skane University Hospital: lead

MeSH Terms

Conditions

Vascular Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Consultant Vascular Surgeon

Model Details: 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

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 25, 2022
• Study Start: March 1, 2013
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2019
• Last Updated: August 8, 2023

Record last verified: 2023-08