BIOSTEMI Extended Survival | NCT05484310

Studies
BIOSTEMI Extended Survival

NCT05484310

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Nov 29, 2023Actual

Enrollment

1,300Actual

Phase

Not provided

Conditions

Coronary Artery Disease
Acute Coronary Syndrome

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

Randomized Multicenter Comparison Between Ultrathin-strut Biodegradable Polymer Sirolimuseluting Stents and Durable Polymer Everolimus-eluting Stents for Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2021Actual

Primary Completion Date

Apr 30, 2023Actual

Completion Date

Oct 28, 2023Actual

First Submitted Date

Jul 29, 2022

First Submission Date that Met QC Criteria

Jul 29, 2022

First Posted Date

Aug 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2023

Last Update Posted Date

Nov 29, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

IGLESIAS Juan Fernando, PD Dr, University Hospital, GenevaPrincipal Investigator

Lead Sponsor

University Hospital, GenevaOTHER

Collaborators

Name	Class
Insel Gruppe AG, University Hospital Bern	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of the BIOSTEMI ES study is to assess the long-term clinical outcomes with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent up to 5 years of follow-up among patients with STEMI undergoing primary PCI, enrolled in the BIOSTEMI trial.

Detailed Description

In the BIOSTEMI randomized controlled clinical trial, the Orsiro ultrathin-strut bio degradable polymer sirolimus-eluting stent was found superior to the best-in-class Xience thin-strut durable polymer everolimus-eluting stent with respect to target lesion failure at one-year follow-up among patients with STEMI undergoing primary PCI (Iglesias JF, et al., Lancet 2019). The difference was driven by a lower risk of clinically indicated target lesion revascularization with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent.
Importantly, the difference between Orsiro stent and Xience stent accrues over time between one and two years of follow-up.
As per study protocol, the planned follow-up of patients included in the BIOSTEMI randomized controlled trial was 2 years.
The long-term clinical benefits the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent over the Xience thin-strut durable polymer everolimus-eluting stent beyond the polymer degradation period remain uncertain.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,300Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Target lesion failure, composite of cardiac death, target vessel (Q-wave or non-Q-wave) myocardial re-infarction, or clinically indicated target lesion revascularization	Clinical assessment	5 years of follow-up

Secondary Outcomes

Measure	Description	Time Frame
Cardiac death	Clinical assessment	5 years of follow-up
All-cause death	Clinical assessment	5 years of follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects that were enrolled in the BIOSTEMI trial (BASEC: 2016-00555),
Subject willing and able to provide oral informed consent.

Exclusion Criteria:

No specific exclusion criteria.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

BIOSTEMI ES includes only participants of the BIOSTEMI trial, i.e. patients with acute STEMI presenting within 24 hours of symptom onset undergoing primary PCI. At PCI, the randomly allocated stent (Orsiro® vs Xience®) was implanted in the culprit lesion of the target vessel.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Pilgrim, Pr	Insel Gruppe AG, University Hospital Bern	Principal Investigator
Juan F. Iglesias, PD Dr	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Aarau		Aarau		5001	Switzerland
Basel University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29205157	Background	Iglesias JF, Muller O, Zaugg S, Roffi M, Kurz DJ, Vuilliomenet A, Weilenmann D, Kaiser C, Tapponnier M, Heg D, Valgimigli M, Eeckhout E, Juni P, Windecker S, Pilgrim T. A comparison of an ultrathin-strut biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent for patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: rationale and design of the BIOSTEMI trial. EuroIntervention. 2018 Aug 20;14(6):692-699. doi: 10.4244/EIJ-D-17-00734.
31488372

ID	Term
D003324	Coronary Artery Disease
D054058	Acute Coronary Syndrome
D000072657	ST Elevation Myocardial Infarction

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases