Ultrathin DES in Complex PCI Scenarios: the ULTRA a Multicenter Study

NCT05205148 | Unknown DMC FDA Device

• 1 other identifier: ULTRA registry
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Incidence of target lesion failure (TLF)

  A composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis

  Up to 2 years

Secondary Outcomes (8)

• Incidence of all-cause death

  Up to 2 years

• Incidence of acute myocardial infarction (AMI)

  Up to 2 years

• Incidence of target vessel revascularization (TVR)

  Up to 2 years

• Incidence of major bleedings

  Up to 2 years

• Incidence of cardiovascular death

  Up to 2 years

Interventions

Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex Cruz DEVICE

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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:
• Orsiro
• Mistent
• BioMime
• Supraflex Cruz

You may not qualify if:

• patients died during the index revascularization procedure

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

Fabrizio D'Ascenzo

Torino, 10126, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 39895551 DERIVED

• De 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.

  PMID: 39492702 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Fabrizio D'Ascenzo, PhD

  AOU Città della Salute e della Scienza Torino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ovidio De Filippo, MD

CONTACT

+390116336023; ovidio.defilippo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 24, 2022
• Study Start: January 1, 2019
• Primary Completion: April 30, 2022
• Study Completion: December 30, 2024
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)