Peripheral Artery Disease (PAD)T3PROJECTNCT05665816
Results of the Treatment of Medium and Long de Novo and Restenotic Lesions in the Superficial Femoral Artery and/or Popliteal Artery With Primary or Salvage Pulsar® -18 t3 Stent
An observational study of Peripheral Artery Disease (PAD), run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia.
Trial summary
The purpose of this post-authorization registry is to describe the clinical outcomes of de novo and restenotic lesions in the superficial femoral and/or popliteal artery treated with the PULSAR® -18 T3 stent, implanted both primary and salvage. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Peripheral Artery Disease (PAD)
- What is being tested?
- Stent PULSAR® -18 T3,
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 15 May 2024
- How long will I take part?
- 24 Months
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the statistical analyzes will be carried out in the group of patients who have the necessary data to evaluate the main objective. Secondary objectives will be analyzed using available data only (missing data imputation techniques will not be used).
Who may be able to join
- I1. Patients with documented PAD from the AFS and/or AP, classified as having intermittent claudication or critical limb ischemia (CLI), with a Rutherford score between 3 and 5.
- I2. Age ≥ 55 years. I3. The target lesion consists of one or multiple de novo or restenotic lesions > 5 cm.
- I4. Adequate run-off distal circulation to the foot (at least one patent, pre-existing, or successfully restored native distal vessel before beginning treatment of the target lesion).
- I5. Adequate in-flow defined as, stenosis ≤ 30% of the diameter (either pre-existing or successfully reestablished before starting treatment of the target lesion).
- I6. CI signed and dated.
Who cannot join
- E1. Failure to successfully cross the target lesion with a guidewire (successful crossing means that the tip of the guidewire is distal to the target lesion, without dissection or perforation that limits blood flow).
- E2. Life expectancy < 12 months.
- E3. Any contraindication to the use of antiplatelet therapy and/or heparin
- E4. Acute or subacute thrombosis in the target vessel.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this post-authorization registry is to describe the clinical outcomes of de novo and restenotic lesions in the superficial femoral and/or popliteal artery treated with the PULSAR® -18 T3 stent, implanted both primary and salvage.
Read the detailed description
Post-authorization, prospective and multicenter registry to evaluate the clinical results of the PULSAR® -18 T3 stent, in the treatment of de novo or restenotic lesions of the superficial femoral and/or popliteal artery, primarily as salvage, in a population of patients residing in Spain and in "real life" conditions.
In this registry, data will be collected from approximately 100 consecutive patients who have been treated with the PULSAR® -18 T3 Stent.
Subjects with PAD treated with the PULSAR® -18 T3 Stent will be assessed for eligibility for the registry and will be consecutively included in the registry. Once informed consent is obtained, the required data will be collected.
- Conditions
- Peripheral Artery Disease (PAD)
- Being tested
- Stent PULSAR® -18 T3,
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent PULSAR® -18 T3,Device
Post-authorization, prospective and multicenter registry to evaluate the clinical results of the PULSAR® -18 T3 stent, in the treatment of de novo or restenotic lesions of the superficial femoral and/or popliteal artery, primarily as salvage, in a population of patients residing in Spain and in "real life" conditions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Subjects with PAD treated with the PULSAR® -18 T3 Stent will be assessed for eligibility for the registry and consecutively included in the registry. Once informed consent is obtained, the required data will be collected. Receives: Device: Stent PULSAR® -18 T3, |
What is being measured
The primary outcome is the main question the study is designed to answer.
No device- or procedure-related mortality
Number of deaths
Measured: Up to 24 months.
No major amputation of the treated limb
Number of amputations
Measured: Up to 24 months.
No revascularization of the target lesion
Number of lesions not revascularized
Measured: Up to 24 months.
Revascularization rate of the clinically indicated target lesion
Number of new intervention of the target lesion, indicated by symptomatology or by a decrease in ABI (Ankle Brachial Index) ≥ 20% or ≥ 0.15 compared to the ABI after the index procedure or, a PSVR (Pick Systolic Velocity Ratio) > 2.4 measured by DUS (Doppler Ultrasound)
Measured: Up to 24 months.
Secondary outcomes (9)
Serious Adverse Event Rates
Number of serious adverse events
Measured: Up to 24 months.
Rate of success of the procedure
Number of Residual stenosis ≤ 50% by visual estimation
Measured: Up to 24 months.
Primary patency
Absence of CD-TLR (clinically indicated TLR) and target lesion restenosis during follow-up, greater than 50% as determined by PSVR > 2.4 according to DUS (Doppler Ultrasound)
Measured: Up to 24 months.
Assisted primary patency.
Patency of the target lesion after reoperation due to any reason, the lesion being patent at that time.
Measured: Up to 24 months.
Secondary patency.
Patency of the target lesion after treatment of a (re)occlusion of the target lesion.
Measured: Up to 24 months.
Rate of Clinical improvement (based on the Rutherford and WIfI classification) or absence of critical ischemia
Number of patients with maintained decrease of minus 1 degree in CR and exit from critical ischemia compared to baseline.
Measured: Up to 24 months.
Rate of patients with major amputation of target limb
Number of surgical removal of the target limb:
- Supracondylar amputation: amputation of the limb with the resection point above the knee.
- Infracondylar amputation: amputation of the limb with the resection point below the knee.
Measured: Up to 24 months.
Hemodynamic improvement
Ankle Brachial Index
Measured: Up to 24 months.
Mortality from any cause
Number of deaths
Measured: Up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start15 Jan 2023 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease (PAD)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Cuenca Manteca, MD, Principal investigator, Hospital Universitario Santa Lucía Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665816
- Sponsor's protocol ID
- IMIB-STN-2022-02
- Acronym
- T3PROJECT
- Status last verified
- Dec 2022
- First submitted
- 16 Dec 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of the Treatment of Medium and Long de Novo and Restenotic Lesions in the Superficial Femoral Artery and/or Popliteal Artery With Primary or Salvage Pulsar® -18 t3 Stent
- ClinicalTrials.gov ID
- NCT05665816
- Acronym / sponsor ID
- T3PROJECT / IMIB-STN-2022-02
- Conditions
- Peripheral Artery Disease (PAD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 27 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.
The purpose of this post-authorization registry is to describe the clinical outcomes of de novo and restenotic lesions in the superficial femoral and/or popliteal artery treated with the PULSAR® -18 T3 stent, implanted both primary and salvage.
Detailed description
Post-authorization, prospective and multicenter registry to evaluate the clinical results of the PULSAR® -18 T3 stent, in the treatment of de novo or restenotic lesions of the superficial femoral and/or popliteal artery, primarily as salvage, in a population of patients residing in Spain and in "real life" conditions.
In this registry, data will be collected from approximately 100 consecutive patients who have been treated with the PULSAR® -18 T3 Stent.
Subjects with PAD treated with the PULSAR® -18 T3 Stent will be assessed for eligibility for the registry and will be consecutively included in the registry. Once informed consent is obtained, the required data will be collected.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Device: Stent PULSAR® -18 T3,Subjects with PAD treated with the PULSAR® -18 T3 Stent will be assessed for eligibility for the registry and consecutively included in the registry. Once informed consent is obtained, the required data will be collected. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the statistical analyzes will be carried out in the group of patients who have the necessary data to evaluate the main objective. Secondary objectives will be analyzed using available data only (missing data imputation techniques will not be used).
Key inclusion criteria (5 listed)
- I1. Patients with documented PAD from the AFS and/or AP, classified as having intermittent claudication or critical limb ischemia (CLI), with a Rutherford score between 3 and 5.
- I2. Age ≥ 55 years. I3. The target lesion consists of one or multiple de novo or restenotic lesions > 5 cm.
- I4. Adequate run-off distal circulation to the foot (at least one patent, pre-existing, or successfully restored native distal vessel before beginning treatment of the target lesion).
- I5. Adequate in-flow defined as, stenosis ≤ 30% of the diameter (either pre-existing or successfully reestablished before starting treatment of the target lesion).
- I6. CI signed and dated.
Key exclusion criteria (4 listed)
- E1. Failure to successfully cross the target lesion with a guidewire (successful crossing means that the tip of the guidewire is distal to the target lesion, without dissection or perforation that limits blood flow).
- E2. Life expectancy < 12 months.
- E3. Any contraindication to the use of antiplatelet therapy and/or heparin
- E4. Acute or subacute thrombosis in the target vessel.
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 |
|---|---|---|
| Stent PULSAR® -18 T3,Post-authorization, prospective and multicenter registry to evaluate the clinical results of the PULSAR® -18 T3 stent, in the treatment of de novo or restenotic lesions of the superficial femoral and/or popliteal artery, primarily as salvage, in a population of patients residing in Spain and in "real life" conditions. | Device | Intervention |
Primary outcome
No device- or procedure-related mortality
Time frame: Up to 24 months.
Number of deaths
No major amputation of the treated limb
Time frame: Up to 24 months.
Number of amputations
No revascularization of the target lesion
Time frame: Up to 24 months.
Number of lesions not revascularized
Revascularization rate of the clinically indicated target lesion
Time frame: Up to 24 months.
Number of new intervention of the target lesion, indicated by symptomatology or by a decrease in ABI (Ankle Brachial Index) ≥ 20% or ≥ 0.15 compared to the ABI after the index procedure or, a PSVR (Pick Systolic Velocity Ratio) > 2.4 measured by DUS (Doppler Ultrasound)
9 secondary outcomes
Serious Adverse Event Rates
Time frame: Up to 24 months.
Rate of success of the procedure
Time frame: Up to 24 months.
Primary patency
Time frame: Up to 24 months.
Assisted primary patency.
Time frame: Up to 24 months.
Secondary patency.
Time frame: Up to 24 months.
Rate of Clinical improvement (based on the Rutherford and WIfI classification) or absence of critical ischemia
Time frame: Up to 24 months.
Rate of patients with major amputation of target limb
Time frame: Up to 24 months.
Hemodynamic improvement
Time frame: Up to 24 months.
Mortality from any cause
Time frame: Up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jorge Cuenca Manteca, MD principal investigator
Hospital Universitario Santa Lucía Murcia
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease (PAD), run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia.
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 4 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 29 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Cuenca Manteca, MD (968128600, jcuencam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No device- or procedure-related mortality (time frame: Up to 24 months.). The study lists 4 primary outcomes in all. 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 29 Dec 2022.