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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05651165
Other study ID # ACV-MIM-2020-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date January 2024

Study information

Verified date December 2022
Source Hospital Universitari de Bellvitge
Contact Carlos M Rico, MD
Phone 034 932 60 75 00
Email carlosmartinezrico@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date January 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Spain Hospital Universitari de Bellvitge L'Hospitalet De Llobregat Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Permeability Degree of arterial permeability after intervention measured by arterial cartography with ultrasound at 3, 6 and 12 months. 12 months
Secondary Limb salvage rate Number (percentage) of limbs that did not undergo further amputation. 12 months
Secondary Limb reintervention rate Number (percentage) of limbs that required reintervention. 12 months
Secondary Deaths Number (percentage) of deaths by any cause. 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT03687983 - Safety and Efficacy Study of GoldenFlow Peripheral Stent System N/A
Recruiting NCT03683459 - Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter N/A
Recruiting NCT06416644 - The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) N/A