Peripheral Arterial DiseaseFESTIVALNCT05821829
Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy
An observational study of Peripheral Arterial Disease and Common Femoral Artery Stenosis, run by University of Pisa at 1 site in Italy.
Trial summary
Prospective, nonrandomized, multicenter, national, multidisciplinary, real-world data collection with the aim to evaluate the short-term safety and efficacy of intravascular lithotripsy in the treatment of steno-obstructive disease of the common femoral artery Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Peripheral Arterial Disease, Common Femoral Artery Stenosis, Common Femoral Artery Occlusion
- What is being tested?
- Intravascular litothripsy (IVL)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 1 May 2025
- How long will I take part?
- 1 Year
- 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 severely symptomatic peripheral arterial disease and concomitant atherosclerotic de novo lesions of the common femoral artery
Who may be able to join
- Patients with peripheral arterial disease (Rutherford class 3-6)
- Presence of a steno-obstructive lesion of the common femoral artery (Azema classification 1-3)
- Possible endovascular treatment of both the iliac axis and/or femoro-distal vessels
- Possible post-dilatation with plain or drug-coated balloon angioplasty
Who cannot join
- Concomitant open surgery (ilio-femoral or femoro-distal bypass)
- Presence of a steno-obstructive lesion of the common femoral artery in previous open surgery (Azema classification 4)
- Presence of a steno-obstructive lesion of the common femoral artery after a previous endovascular procedure
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Pisa
Pisa, 50012
Nicola Troisi, Prof, 00393280205530, nicola.troisi@unipi.it
About this study
Official title: Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy: the FESTIVAL Registry
Prospective, nonrandomized, multicenter, national, multidisciplinary, real-world data collection with the aim to evaluate the short-term safety and efficacy of intravascular lithotripsy in the treatment of steno-obstructive disease of the common femoral artery
- Conditions
- Peripheral Arterial Disease, Common Femoral Artery Stenosis, Common Femoral Artery Occlusion, Critical Limb-Threatening Ischemia
- Being tested
- Intravascular litothripsy (IVL)
- 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.
Intravascular litothripsy (IVL)Device
endovascular treatment of primary common femoral artery atherosclerotic disease with intravascular litothripsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
insertion/use of the device after crossing the steno-obstructive lesion and its removal without complications, restoration of vessel patency in the absence of stenosis/acute recoil >30%, rupture/perforation of the common femoral artery, need for a bailout stenting
Measured: Intraprocedural
Clinical success
absence of intraprocedural complications including distal embolization and improvement of at least 1 Rutherford class assessed 1 month after the procedure
Measured: Intraprocedural / 1 month
Primary patency
patency of the treated vessel in the absence of a restenosis >30%
Measured: 1 month / 6 months / 1 year
Primary assisted patency
patency of the treated vessel after one or more endovascular reinterventions
Measured: 1 month / 6 months / 1 year
Secondary patency
patency of the treated vessel after occlusione and treatment by surgical or endovascular means
Measured: 1 month / 6 months / 1 year
Clinically driven freedom from target lesion restenosis (cdTLR)
restenosis resulting in vessel occlusion or stenosis with maximum PSV > 2.5 m/sec
Measured: 1 month / 6 months / 1 year
Secondary outcomes (3)
Freedom from any reinterventions
Measured: 1 month / 6 months / 1 year
Patency of profunda femoris
Measured: 1 month / 6 months / 1 year
Limb salvage
Measured: 1 month / 6 months / 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 May 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Troisi, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821829
- Sponsor's protocol ID
- FESTIVAL
- Acronym
- FESTIVAL
- Status last verified
- May 2023
- First submitted
- 7 Apr 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baig M, Kwok M, Aldairi A, Imran HM, Khan MS, Moustafa A, Hyder ON, Saad M, Aronow HD, Soukas PA. Endovascular Intravascular Lithotripsy in the Treatment of Calcific Common Femoral Artery Disease: A Case Series With an 18-Month Follow-Up. Cardiovasc Revasc Med. 2022 Oct;43:80-84. doi: 10.1016/j.carrev.2022.05.003. Epub 2022 May 7.
PubMed 35595607Wong CP, Chan LP, Au DM, Chan HWC, Chan YC. Efficacy and Safety of Intravascular Lithotripsy in Lower Extremity Peripheral Artery Disease: A Systematic Review and Meta-Analysis. Eur J Vasc Endovasc Surg. 2022 Mar;63(3):446-456. doi: 10.1016/j.ejvs.2021.10.035. Epub 2021 Dec 6.
PubMed 34887206Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.
PubMed 34167675
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy: the FESTIVAL Registry
- ClinicalTrials.gov ID
- NCT05821829
- Acronym / sponsor ID
- FESTIVAL / FESTIVAL
- Conditions
- Peripheral Arterial Disease, Common Femoral Artery Stenosis, Common Femoral Artery Occlusion, Critical Limb-Threatening Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 20 Apr 2023 (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.
Prospective, nonrandomized, multicenter, national, multidisciplinary, real-world data collection with the aim to evaluate the short-term safety and efficacy of intravascular lithotripsy in the treatment of steno-obstructive disease of the common femoral artery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severely symptomatic peripheral arterial disease and concomitant atherosclerotic de novo lesions of the common femoral artery
Key inclusion criteria (4 listed)
- Patients with peripheral arterial disease (Rutherford class 3-6)
- Presence of a steno-obstructive lesion of the common femoral artery (Azema classification 1-3)
- Possible endovascular treatment of both the iliac axis and/or femoro-distal vessels
- Possible post-dilatation with plain or drug-coated balloon angioplasty
Key exclusion criteria (3 listed)
- Concomitant open surgery (ilio-femoral or femoro-distal bypass)
- Presence of a steno-obstructive lesion of the common femoral artery in previous open surgery (Azema classification 4)
- Presence of a steno-obstructive lesion of the common femoral artery after a previous endovascular procedure
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 |
|---|---|---|
| Intravascular litothripsy (IVL)endovascular treatment of primary common femoral artery atherosclerotic disease with intravascular litothripsy | Device | – |
Primary outcome
Technical success
Time frame: Intraprocedural
insertion/use of the device after crossing the steno-obstructive lesion and its removal without complications, restoration of vessel patency in the absence of stenosis/acute recoil >30%, rupture/perforation of the common femoral artery, need for a bailout stenting
Clinical success
Time frame: Intraprocedural / 1 month
absence of intraprocedural complications including distal embolization and improvement of at least 1 Rutherford class assessed 1 month after the procedure
Primary patency
Time frame: 1 month / 6 months / 1 year
patency of the treated vessel in the absence of a restenosis >30%
Primary assisted patency
Time frame: 1 month / 6 months / 1 year
patency of the treated vessel after one or more endovascular reinterventions
Secondary patency
Time frame: 1 month / 6 months / 1 year
patency of the treated vessel after occlusione and treatment by surgical or endovascular means
Clinically driven freedom from target lesion restenosis (cdTLR)
Time frame: 1 month / 6 months / 1 year
restenosis resulting in vessel occlusion or stenosis with maximum PSV > 2.5 m/sec
3 secondary outcomes
Freedom from any reinterventions
Time frame: 1 month / 6 months / 1 year
Patency of profunda femoris
Time frame: 1 month / 6 months / 1 year
Limb salvage
Time frame: 1 month / 6 months / 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Results publication: PubMed 35595607Baig M, Kwok M, Aldairi A, Imran HM, Khan MS, Moustafa A, Hyder ON, Saad M, Aronow HD, Soukas PA. Endovascular Intravascular Lithotripsy in the Treatment of Calcific Common Femoral Artery Disease: A Case Series With an 18-Month Follow-Up. Cardiovasc Revasc Med. 2022 Oct;43:80-84. doi: 10.1016/j.carrev.2022.05.003. Epub 2022 May 7.
- Results publication: PubMed 34887206Wong CP, Chan LP, Au DM, Chan HWC, Chan YC. Efficacy and Safety of Intravascular Lithotripsy in Lower Extremity Peripheral Artery Disease: A Systematic Review and Meta-Analysis. Eur J Vasc Endovasc Surg. 2022 Mar;63(3):446-456. doi: 10.1016/j.ejvs.2021.10.035. Epub 2021 Dec 6.
- Results publication: PubMed 34167675Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Common Femoral Artery Stenosis, run by University of Pisa at 1 site in Italy.
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 4 inclusion and 3 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 10 May 2023. 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 Italy. 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 Nicola Troisi, Prof (00393280205530, nicola.troisi@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Intraprocedural). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05821829, which also lists 3 linked publications.
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 10 May 2023.