Drug-Eluting Balloons vs Mimetic Stents for Popliteal Artery Disease

Comparative Study Between Drug-Eluting Balloons and Mimetic Stents for Popliteal Artery Disease Treatment in Patients With Chronic Lower Limb Ischemia

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.

Study Overview

• Status: Recruiting
• Conditions: Popliteal Arterial Stenosis
• Intervention / Treatment: Device: Pharmacoactive balloon angioplasty. Lutonix®; Device: Mimetic stent.Supera®

Detailed Description

Arteriosclerosis is a systemic and multi-etiological disease that causes arterial degeneration, narrowing their lumens and reducing perfusion in their respective territories. Chronic lower limb ischemia is one manifestation of arteriosclerosis. It may be initially asymptomatic, but patients usually present with pulselessness and intermittent lower limb claudication. More advanced and severe cases present with rest pain, the so-called critical lower limb ischemia.

Critical lower limb ischemia usually benefits from revascularization and requires cautious surgical planning with complementary imaging tests able to locate the lesion site precisely. In our setting, the most used test is arterial cartography with doppler ultrasound. Afterward, surgeons should decide whether to perform open surgery or endovascular treatment.

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. Given its anatomy, the popliteal artery undergoes many flexion-extension and rotational movements, making it a challenging site for balloon angioplasty alone (high incidence of restenosis) and standard nitinol stenting angioplasty (risk of stent fractures).

Mimetic stents have been developed to overcome the risk of stent fractures. They consist of multiple intertwined nitinol wires that provide greater radial resistance and allow for even stress distribution.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlos M Rico, MD; Phone Number: 034 932 60 75 00; Email: carlosmartinezrico@gmail.com
• Study Contact Backup: Name: Malka Huici, MD; Phone Number: 034 932 60 75 00; Email: malkahuici@gmail.com

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Hospital Universitari de Bellvitge
      • Contact: Carlos M Rico, MD; Phone Number: 034 932 60 75 00; Email: carlosmartinezrico@gmail.com
      • Contact: Malka Huici, MD; Phone Number: 034 932 60 75 00; Email: malkahuici@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Patients receiving pharmacoactive balloon angioplasty. Lutonix®	Device: Pharmacoactive balloon angioplasty. Lutonix®; Percutaneous transluminal angioplasty with paclitaxel-coated balloon in the arteriosclerosis site to increase blood-flow to the distal arterial areas.
Experimental: Group B; Patients receiving mimetic stent. Supera®	Device: Mimetic stent.Supera®; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Permeability	Degree of arterial permeability after intervention measured by arterial cartography with ultrasound at 3, 6 and 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limb salvage rate	Number (percentage) of limbs that did not undergo further amputation.	12 months
Limb reintervention rate	Number (percentage) of limbs that required reintervention.	12 months
Deaths	Number (percentage) of deaths by any cause.	12 months

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Principal Investigator: Xavier M Mestre, MD, Vascular Surgeon Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Estimate): December 14, 2022

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Chronic lower limb ischemia; Popliteal artery stenosis; Mimetic stent; Pharmacoactive balloon angioplasty
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: ACV-MIM-2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No