Popliteal Arterial StenosisNCT05651165
Drug-Eluting Balloons vs Mimetic Stents for Popliteal Artery Disease
A study testing Pharmacoactive balloon angioplasty. Lutonix® and Mimetic stent.Supera® in people with Popliteal Arterial Stenosis, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Popliteal Arterial Stenosis
- What is being tested?
- Pharmacoactive balloon angioplasty. Lutonix® and Mimetic stent.Supera®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2021to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Carlos M Rico, MD, 034 932 60 75 00, carlosmartinezrico@gmail.com
Malka Huici, MD, 034 932 60 75 00, malkahuici@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Popliteal Arterial Stenosis
- Being tested
- Pharmacoactive balloon angioplasty. Lutonix®, Mimetic stent.Supera®
- Keywords
- Popliteal artery stenosis, Mimetic stent, Pharmacoactive balloon angioplasty, Chronic lower limb ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients receiving pharmacoactive balloon angioplasty. Lutonix® Receives: Device: Pharmacoactive balloon angioplasty. Lutonix® |
| Group B | Experimental | Patients receiving mimetic stent. Supera® Receives: Device: Mimetic stent.Supera® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Permeability
Degree of arterial permeability after intervention measured by arterial cartography with ultrasound at 3, 6 and 12 months.
Measured: 12 months
Secondary outcomes (3)
Limb salvage rate
Number (percentage) of limbs that did not undergo further amputation.
Measured: 12 months
Limb reintervention rate
Number (percentage) of limbs that required reintervention.
Measured: 12 months
Deaths
Number (percentage) of deaths by any cause.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Dec 2021
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Popliteal Arterial StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, parallel-group, randomized (1:1) clinical trial.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Martínez Rico, Hospital Universitari de Bellvitge
- Investigators
- Xavier M Mestre, MD, Principal investigator, Vascular Surgeon Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651165
- Sponsor's protocol ID
- ACV-MIM-2020-01
- Status last verified
- Dec 2022
- First submitted
- 23 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Drug-Eluting Balloons and Mimetic Stents for Popliteal Artery Disease Treatment in Patients With Chronic Lower Limb Ischemia
- ClinicalTrials.gov ID
- NCT05651165
- Acronym / sponsor ID
- ACV-MIM-2020-01
- Conditions
- Popliteal Arterial Stenosis
- Keywords
- Popliteal artery stenosis, Mimetic stent, Pharmacoactive balloon angioplasty, Chronic lower limb ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, parallel-group, randomized (1:1) clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Pharmacoactive balloon angioplasty. Lutonix®Patients receiving pharmacoactive balloon angioplasty. Lutonix® |
| Group B | Experimental | Device: Mimetic stent.Supera®Patients receiving mimetic stent. Supera® |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacoactive balloon angioplasty. Lutonix®Percutaneous transluminal angioplasty with paclitaxel-coated balloon in the arteriosclerosis site to increase blood-flow to the distal arterial areas. | Device | Group A |
| 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. | Device | Group B |
Primary outcome
Permeability
Time frame: 12 months
Degree of arterial permeability after intervention measured by arterial cartography with ultrasound at 3, 6 and 12 months.
3 secondary outcomes
Limb salvage rate
Time frame: 12 months
Limb reintervention rate
Time frame: 12 months
Deaths
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Popliteal Arterial Stenosis
Active, not recruiting
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Superficial Femoral Artery Stenosis, Popliteal Artery Stenosis
Not yet recruitingPhase 2/3
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Popliteal Artery Disease, Superficial Femoral Artery Disease
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SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
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Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease
Superficial Femoral Artery Stenosis, Iliac Artery Stenosis
Active, not recruiting
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
Lower Limb Ischemia, Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier M Mestre, MD principal investigator
Vascular Surgeon Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacoactive balloon angioplasty. Lutonix® and Mimetic stent.Supera® in people with Popliteal Arterial Stenosis, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos M Rico, MD (034 932 60 75 00, carlosmartinezrico@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Permeability (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.