Coronary Artery DiseaseULTRANCT05205148
Ultrathin DES in Complex PCI Scenarios: the ULTRA a Multicenter Study
An observational study of Coronary Artery Disease and Coronary Stenosis, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
ULTRA is a multicenter, observational, retrospective registry, enrolling consecutive patients treated with ultrathin coronary DES (coronary stent with strut thickness < 70 um) for coronary bifurcation lesions, left main disease, chronic total coronary occlusion, and in-stent restenosis regardless of their clinical… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis, Stent Restenosis
- What is being tested?
- Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex Cruz
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 30 Dec 2024
- How long will I take part?
- 12 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients treated with ultrathin coronary DES for coronary bifurcation lesions, left main disease, chronic total coronary occlusion and in-stent restenosis regardless of their clinical presentation
Who may be able to join
- age > 18 years old
- Unprotected left main stenosis
- Bifurcation coronary stenosis (with side branch diameter ≥ 2.5 mm)
- Chronic total coronary occlusion
- In-stent restenosis
- Treated with the following devices:
Show all 10Show fewer
- Orsiro
- Mistent
- BioMime
- Supraflex Cruz
Who cannot join
- patients died during the index revascularization procedure
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fabrizio D'Ascenzo
Torino, 10126
Fabrizio D'Ascenzo, PhD, 0116336705, fabrizio.dascenzo@gmail.com
About this study
Official title: Ultrathin Drug Eluting Stents for Patients With Left-main, bifurcaTion, chRonic totAl Occlusion, or In-stent Restenosis Coronary Lesion in Real Life: the ULTRA a Multicenter Study
ULTRA is a multicenter, observational, retrospective registry, enrolling consecutive patients treated with ultrathin coronary DES (coronary stent with strut thickness < 70 um) for coronary bifurcation lesions, left main disease, chronic total coronary occlusion, and in-stent restenosis regardless of their clinical presentation. Target lesion failure (TLF a composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis) will be the primary end point, while its single components will be the secondary ones along with all-cause death, all acute myocardial infarction (excluding peri-procedural AMI), target vessel revascularization and BARC major bleedings (BARC 3-5). Due to the retrospective, observational nature of the registry, no formal sample size estimation is required. Patients complying with detailed inclusion criteria and with a minimum follow up of 6 months will be enrolled.
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Stent Restenosis, Left Main Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery
- Being tested
- Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex Cruz
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex CruzDevice
Patients treated with ultrathin coronary stents (namely stents with strut thickness < 70 um) for specific coronary disease scenarios: unprotected left main stenosis; Bifurcation coronary stenosis (with side branch diameter ≥ 2.5 mm); Chronic total coronary occlusion; In-stent restenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of target lesion failure (TLF)
A composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis
Measured: Up to 2 years
Secondary outcomes (8)
Incidence of all-cause death
death from any cause
Measured: Up to 2 years
Incidence of acute myocardial infarction (AMI)
all acute myocardial infarction excluding peri-procedural myocardial infarction
Measured: Up to 2 years
Incidence of target vessel revascularization (TVR)
All revascularization in a vessel treated with ultrathin DES within the index procedure
Measured: Up to 2 years
Incidence of major bleedings
Major bleedings defined according to Bleeding Academic Research Consortium (BARC 3-5)
Measured: Up to 2 years
Incidence of cardiovascular death
Death from cardiovascular causes
Measured: Up to 2 years
Incidence of target Vessel Myocardial Infarction
Myocardial infarction whose culprit artery is unequivocally identified as an artery treated with ultrathin Drug eluting stent within the index procedure
Measured: Up to 2 years
Incidence of target lesion revascularization
coronary revascularization due to acute coronary syndrome or stable ischemic presentation due to a lesion previously treated with ultrathin drug eluting stent within the index procedure
Measured: Up to 2 years
Incidence of definite stent thrombosis
stent thrombosis in a coronary segment previously treated with ultrathin drug eluting stent
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jan 2019
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio D'Ascenzo, A.O.U. Città della Salute e della Scienza
- Investigators
- Fabrizio D'Ascenzo, PhD, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205148
- Sponsor's protocol ID
- ULTRA registry
- Acronym
- ULTRA
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Choi KH, Nam CW, Bruno F, Cho YK, De Luca L, Kang J, Mattesini A, Song YB, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, Helft G, Han SH, Cortese B, Lee CH, Escaned J, Yoon HJ, Chieffo A, Hahn JY, Gallone G, Choi SH, De Ferrari G, Koo BK, Quadri G, Hur SH, D'Ascenzo F, Gwon HC, de Filippo O. Differential Prognosis of True Bifurcation Lesions According to Left Main Versus Non-Left Main Location and Treatment Strategy. J Am Heart Assoc. 2025 Feb 4;14(3):e037657. doi: 10.1161/JAHA.124.037657. Epub 2025 Feb 3.
PubMed 39895551De Filippo O, Wanha W, Sanavia T, Januszek R, Giacobbe F, Campo G, Pinxterhuis TH, Capodanno D, Tomasiewicz B, Iannaccone M, Leone A, Wolny R, Bruno F, Patti G, Musumeci G, Liccardo G, Verardi R, Roubin SR, Tarantini G, Kuzma L, Perl L, Gagnor A, Reczuch K, Conrotto F, Tuttolomondo D, Ploumen EH, Niezgoda P, Caglioni S, Omede P, Greco A, Kubica J, Gil RJ, Piccolo R, Kornowski R, Bil J, Morena A, Zocca P, Pennone M, Gasior M, Jaguszewski M, von Birgelen C, Fariselli P, De Ferrari GM, Wojakowski W, D'Ascenzo F. Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry. EuroIntervention. 2024 Nov 4;20(21):e1340-e1354. doi: 10.4244/EIJ-D-24-00491.
PubMed 39492702
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrathin Drug Eluting Stents for Patients With Left-main, bifurcaTion, chRonic totAl Occlusion, or In-stent Restenosis Coronary Lesion in Real Life: the ULTRA a Multicenter Study
- ClinicalTrials.gov ID
- NCT05205148
- Acronym / sponsor ID
- ULTRA / ULTRA registry
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Stent Restenosis, Left Main Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 24 Jan 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.
ULTRA is a multicenter, observational, retrospective registry, enrolling consecutive patients treated with ultrathin coronary DES (coronary stent with strut thickness < 70 um) for coronary bifurcation lesions, left main disease, chronic total coronary occlusion, and in-stent restenosis regardless of their clinical presentation. Target lesion failure (TLF a composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis) will be the primary end point, while its single components will be the secondary ones along with all-cause death, all acute myocardial infarction (excluding peri-procedural AMI), target vessel revascularization and BARC major bleedings (BARC 3-5). Due to the retrospective, observational nature of the registry, no formal sample size estimation is required. Patients complying with detailed inclusion criteria and with a minimum follow up of 6 months will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients treated with ultrathin coronary DES for coronary bifurcation lesions, left main disease, chronic total coronary occlusion and in-stent restenosis regardless of their clinical presentation
Key inclusion criteria (10 listed)
- age > 18 years old
- Unprotected left main stenosis
- Bifurcation coronary stenosis (with side branch diameter ≥ 2.5 mm)
- Chronic total coronary occlusion
- In-stent restenosis
Key exclusion criteria (1 listed)
- patients died during the index revascularization 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 |
|---|---|---|
| Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex CruzPatients treated with ultrathin coronary stents (namely stents with strut thickness < 70 um) for specific coronary disease scenarios: unprotected left main stenosis; Bifurcation coronary stenosis (with side branch diameter ≥ 2.5 mm); Chronic total coronary occlusion; In-stent restenosis | Device | – |
Primary outcome
Incidence of target lesion failure (TLF)
Time frame: Up to 2 years
A composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis
8 secondary outcomes
Incidence of all-cause death
Time frame: Up to 2 years
Incidence of acute myocardial infarction (AMI)
Time frame: Up to 2 years
Incidence of target vessel revascularization (TVR)
Time frame: Up to 2 years
Incidence of major bleedings
Time frame: Up to 2 years
Incidence of cardiovascular death
Time frame: Up to 2 years
Incidence of target Vessel Myocardial Infarction
Time frame: Up to 2 years
Incidence of target lesion revascularization
Time frame: Up to 2 years
Incidence of definite stent thrombosis
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Derived from this study: PubMed 39895551Choi KH, Nam CW, Bruno F, Cho YK, De Luca L, Kang J, Mattesini A, Song YB, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, Helft G, Han SH, Cortese B, Lee CH, Escaned J, Yoon HJ, Chieffo A, Hahn JY, Gallone G, Choi SH, De Ferrari G, Koo BK, Quadri G, Hur SH, D'Ascenzo F, Gwon HC, de Filippo O. Differential Prognosis of True Bifurcation Lesions According to Left Main Versus Non-Left Main Location and Treatment Strategy. J Am Heart Assoc. 2025 Feb 4;14(3):e037657. doi: 10.1161/JAHA.124.037657. Epub 2025 Feb 3.
- Derived from this study: PubMed 39492702De Filippo O, Wanha W, Sanavia T, Januszek R, Giacobbe F, Campo G, Pinxterhuis TH, Capodanno D, Tomasiewicz B, Iannaccone M, Leone A, Wolny R, Bruno F, Patti G, Musumeci G, Liccardo G, Verardi R, Roubin SR, Tarantini G, Kuzma L, Perl L, Gagnor A, Reczuch K, Conrotto F, Tuttolomondo D, Ploumen EH, Niezgoda P, Caglioni S, Omede P, Greco A, Kubica J, Gil RJ, Piccolo R, Kornowski R, Bil J, Morena A, Zocca P, Pennone M, Gasior M, Jaguszewski M, von Birgelen C, Fariselli P, De Ferrari GM, Wojakowski W, D'Ascenzo F. Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry. EuroIntervention. 2024 Nov 4;20(21):e1340-e1354. doi: 10.4244/EIJ-D-24-00491.
- 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.
Fabrizio D'Ascenzo, PhD principal investigator
A.O.U. Città della Salute e della Scienza
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 Coronary Artery Disease and Coronary Stenosis, run by A.O.U. Città della Salute e della Scienza 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 10 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: status not confirmed, as of the sponsor's last update on 24 Jan 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 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 Ovidio De Filippo, MD (+390116336023, ovidio.defilippo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of target lesion failure (TLF) (time frame: Up to 2 years). 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 NCT05205148, which also lists 2 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 24 Jan 2022.