Drug-Eluting Balloons vs Mimetic Stents for Popliteal Artery Disease

NCT05651165 | Unknown

• 1 other identifier: ACV-MIM-2020-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

More advanced and severe cases of chronic lower limb ischemia (the so-called critical lower limb ischemia) are painful and limiting conditions that impact on patients' quality of life. Until now, the available evidence for the femoropopliteal area only defines open surgery or endovascular treatment indications. However, the best strategy for endovascular procedures is still unclear. The popliteal artery is a challenging anatomical site for balloon angioplasty alone and standard nitinol stenting angioplasty. This randomized clinical trial aims to assess the superiority of nitinol stent angioplasty compared to pharmacoactive balloon angioplasty to treat critical lower limb ischemia due to popliteal artery arteriosclerosis.

Conditions

Popliteal Arterial Stenosis

Keywords

Popliteal artery stenosis; Mimetic stent; Pharmacoactive balloon angioplasty; Chronic lower limb ischemia

Outcome Measures

Primary Outcomes (1)

• Permeability

  Degree of arterial permeability after intervention measured by arterial cartography with ultrasound at 3, 6 and 12 months.

  12 months

Secondary Outcomes (3)

• Limb salvage rate

  12 months

• Limb reintervention rate

  12 months

• Deaths

  12 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients receiving pharmacoactive balloon angioplasty. Lutonix®

Device: Pharmacoactive balloon angioplasty. Lutonix®

Group B

EXPERIMENTAL

Patients receiving mimetic stent. Supera®

Device: Mimetic stent.Supera®

Interventions

Pharmacoactive balloon angioplasty. Lutonix® DEVICE

Percutaneous transluminal angioplasty with paclitaxel-coated balloon in the arteriosclerosis site to increase blood-flow to the distal arterial areas.

Group A

Mimetic stent.Supera® DEVICE

Multiple intertwined nitinol wires that provide greater radial resistance and allow for even stress distribution. Implanted through percutaneous transluminal angioplasty in the arteriosclerosis site to increase blood-flow to the distal arterial areas.

Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed of critical lower limb ischemia according to the TASC (TransAtlantic Inter-Society Consensus) working group.
• Patients admitted to the Vascular Surgery Department of the Bellvitge Hospital University to treat critical lower limb ischemia for endovascular treatment.
• With involvement of the Popliteal artery in-between the Hunter's canal and the start of the tibial artery branch.
• WOCBP must use highly effective methods of contraception.
• Patients who sign the written informed consent.

You may not qualify if:

• Patients diagnosed of critical lower limb ischemia according to the TASC working group undergoing medical treatment or open surgery.
• Patients requiring amputation.
• Patients who underwent previous revascularization of the same limb (same artery).
• The main involvement is from an arterial territory other than the popliteal artery.
• Pregnant women.
• Inability of overcoming the arterial lesion during the endovascular procedure.
• Affected artery's diameter \<4 mm.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Study Officials

• Xavier M Mestre, MD

  Vascular Surgeon Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos M Rico, MD

CONTACT

034 932 60 75 00; carlosmartinezrico@gmail.com

Malka Huici, MD

CONTACT

034 932 60 75 00; malkahuici@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgeon

Model Details: Open label, parallel-group, randomized (1:1) clinical trial.

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 14, 2022
• Study Start: December 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)