Popliteal Artery StenosisNCT05617053
DAART vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY LESIONS
An observational study of Popliteal Artery Stenosis and Atheroma, run by Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery.
Trial summary
The purpose of this study was to compare the results of directional atherectomy with antirestenotic therapy (DAART technique) and angioplasty/Supera stenting for the treatment of popliteal atherectomy lesions. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Popliteal Artery Stenosis, Atheroma
- What is being tested?
- DAART and ATP/Supera stenting
- Type of treatment
- Medical device
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Oct 2022
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with lifestyle limiting intermittent claudication, ischemic rest pain, ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented atherosclerotic lesions in the popliteal artery undergoing endovascular treatment by DAART of PTA/Supera stenting and at least a 12-months of follow-up
Who may be able to join
- patients with lifestyle limiting intermittent claudication ischemic rest pain, ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented atherosclerotic lesions in the popliteal artery undergoing endovascular treatment by DAART of PTA/Supera stenting and at least a 12-months of follow-up
Who cannot join
- Exclusion criteria were patients who could not receive antiplatelet or anticoagulation therapies. Other exclusion criteria were patients with aneurysm of the ipsilateral superficial femoral artery or popliteal artery, acute thrombus, unsalvageable limb, very limited life-expectancy or with doubts in their willingness or capability to allow follow-up examinations.
About this study
Official title: DIRECTIONAL ATHERECTOMY WITH ANTIRESTENOTIC THERAPY vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY ATHEROSCLEROTIC LESIONS: A CASE-MATCH PROPENSITY STUDY
The purpose of this study was to compare the results of directional atherectomy with antirestenotic therapy (DAART technique) and angioplasty/Supera stenting for the treatment of popliteal atherectomy lesions.
Read the detailed description
Atherectomy offers a way to improve the chances to avoid stent placement, although it did not show superiority in terms of vessel patency or limb salvage compared with POBA. Nevertheless, atherectomy can modify the plaque morphology and the mechanical properties of the baseline disease, which allows better drug penetration and diffusion into the vessel wall.
Moreover, the combination of directional atherectomy devices and drug coated balloons (directional atherectomy with antirestenotic therapy, DAART), theoretically might further improve the clinical outcomes of drug coated angioplasty. The "leave nothing behind" strategies have gained support among interventionalist. Many studies claim that atherectomy improves results when combined with adjunctive DCB.
The Supera stent, when compared with other self-expanding nitinol stents, has proven to deforms less with knee flexion and exhibits less strain. It mimics the natura structure and movement of the anatomy and optimizes luminal gain maintaining a round open lumen in challenging anatomies, as the popliteal artery. Mechanical scaffolding is often required owing to elastic recoil and flow-limiting dissections in complex popliteal lesions.
The purpose to this study was to retrospectively evaluate the efficacy of both techniques for endovascular treatment of atherosclerotic lesions of the popliteal artery.
- Conditions
- Popliteal Artery Stenosis, Atheroma
- Being tested
- DAART, ATP/Supera stenting
- Keywords
- Popliteal artery, Drug-coated balloon, Supera stent, Directional atherectomy
- Medical subject headings
- Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAARTDevice
ATP/Supera stentingDevice
| Study group | Role | What they receive |
|---|---|---|
| DAART | Popliteal artery lesion treated by directional atherectomy with anti-restenotic therapy for the treatment of popliteal atherosclerotic lesions. Receives: Device: DAART | |
| ATP/Supera stenting | Angioplasty and Supera stent implantation for the treatment of popliteal atherosclerotic lesions. Receives: Device: ATP/Supera stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary latency 12-months
primary patency at 12-months follow-up, defined as absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions
Measured: 12 months
Secondary outcomes (7)
Secondary Patency
Secondary patency was defined as requiring a secondary intervention to restore patency after occlusion of the treated segment
Measured: 12-months
Mortality
Patients dead all-cause during follow-up
Measured: 12-months
Amputation rate
Patients with minor or mayor amputation during follow-up
Measured: 12-months
Clinical status
Rutherford classification clinical scale after 12-month follow-up
Measured: 12-months
ABI measurement
Ankle/Brachial index measurement.
Measured: 12-months
Stent fracture
Stent fracture and implantation defects were assessed by high-resolution radiographic imaging performed on the stents of every limb
Measured: 12-months
Primary-assisted patency
Primary assisted patency was defined as a patent popliteal segment that underwent further intervention within the inflow, treated vessel segment, or outflow of the treated vessel segment to improve patency
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 posted15 Nov 2022
- Study start1 Jan 2016
- Primary completion1 Jan 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Popliteal Artery 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Enrique M. San Norberto, Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617053
- Sponsor's protocol ID
- PI 22-2967
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 15 Nov 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 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIRECTIONAL ATHERECTOMY WITH ANTIRESTENOTIC THERAPY vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY ATHEROSCLEROTIC LESIONS: A CASE-MATCH PROPENSITY STUDY
- ClinicalTrials.gov ID
- NCT05617053
- Acronym / sponsor ID
- PI 22-2967
- Conditions
- Popliteal Artery Stenosis, Atheroma
- Keywords
- Popliteal artery, Drug-coated balloon, Supera stent, Directional atherectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Vascular Investigation Network Spanish Society for Angiology and Vascular SurgeryResearch network
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 15 Nov 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.
The purpose of this study was to compare the results of directional atherectomy with antirestenotic therapy (DAART technique) and angioplasty/Supera stenting for the treatment of popliteal atherectomy lesions.
Detailed description
Atherectomy offers a way to improve the chances to avoid stent placement, although it did not show superiority in terms of vessel patency or limb salvage compared with POBA. Nevertheless, atherectomy can modify the plaque morphology and the mechanical properties of the baseline disease, which allows better drug penetration and diffusion into the vessel wall.
Moreover, the combination of directional atherectomy devices and drug coated balloons (directional atherectomy with antirestenotic therapy, DAART), theoretically might further improve the clinical outcomes of drug coated angioplasty. The "leave nothing behind" strategies have gained support among interventionalist. Many studies claim that atherectomy improves results when combined with adjunctive DCB.
The Supera stent, when compared with other self-expanding nitinol stents, has proven to deforms less with knee flexion and exhibits less strain. It mimics the natura structure and movement of the anatomy and optimizes luminal gain maintaining a round open lumen in challenging anatomies, as the popliteal artery. Mechanical scaffolding is often required owing to elastic recoil and flow-limiting dissections in complex popliteal lesions.
The purpose to this study was to retrospectively evaluate the efficacy of both techniques for endovascular treatment of atherosclerotic lesions of the popliteal artery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAART | – | Device: DAARTPopliteal artery lesion treated by directional atherectomy with anti-restenotic therapy for the treatment of popliteal atherosclerotic lesions. |
| ATP/Supera stenting | – | Device: ATP/Supera stentingAngioplasty and Supera stent implantation for the treatment of popliteal atherosclerotic lesions. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with lifestyle limiting intermittent claudication, ischemic rest pain, ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented atherosclerotic lesions in the popliteal artery undergoing endovascular treatment by DAART of PTA/Supera stenting and at least a 12-months of follow-up
Key inclusion criteria (1 listed)
- patients with lifestyle limiting intermittent claudication ischemic rest pain, ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented atherosclerotic lesions in the popliteal artery undergoing endovascular treatment by DAART of PTA/Supera stenting and at least a 12-months of follow-up
Key exclusion criteria (1 listed)
- Exclusion criteria were patients who could not receive antiplatelet or anticoagulation therapies. Other exclusion criteria were patients with aneurysm of the ipsilateral superficial femoral artery or popliteal artery, acute thrombus, unsalvageable limb, very limited life-expectancy or with doubts in their willingness or capability to allow follow-up examinations.
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 |
|---|---|---|
| DAART | Device | DAART |
| ATP/Supera stenting | Device | ATP/Supera stenting |
Primary outcome
Primary latency 12-months
Time frame: 12 months
primary patency at 12-months follow-up, defined as absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions
7 secondary outcomes
Secondary Patency
Time frame: 12-months
Mortality
Time frame: 12-months
Amputation rate
Time frame: 12-months
Clinical status
Time frame: 12-months
ABI measurement
Time frame: 12-months
Stent fracture
Time frame: 12-months
Primary-assisted patency
Time frame: 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Popliteal Artery Stenosis and Atheroma, run by Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary latency 12-months (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 15 Nov 2022.