Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex

Skane University Hospital

Status: Completed

Conditions: Vascular Diseases

Treatments: Device: Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions; Device: Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions

Study type: Interventional

Funder types: Other

Identifiers

NCT05296031

TF2

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

49 participants in 2 patient groups, including a placebo group

Drug Eluting Stent (DES)

Active Comparator group

Description:

Drug Eluting Stent (DES). Zilver PTX.

Treatment:

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

Bare Metal Stent (BMS)

Placebo Comparator group

Description:

Bare Metal Stent (BMS). Zilver Flex

Treatment:

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