NCT02398955

Brief Summary

Biomime stent is a novel sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer licensed for the treatment of de novo coronary lesions. However no data regarding the efficacy and safety of this stent in an "all-comers" patient population treated with percutaneus coronary interventions (PCI) have been published so far. In this registry the investigators aimed to collect clinical and angiographic information about an extensive "all-comers" employ of this novel stent.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

March 22, 2015

Last Update Submit

March 25, 2015

Conditions

Coronary Artery Disease

Keywords

Drug-Eluting StentsCoronary Artery DiseaseSirolimusAbsorbable Implants

Outcome Measures

Primary Outcomes (1)

  • target vessel revascularization

    rate of target vessel percutaneous or surgical reintervention for recurrent symptoms or inducible ischemia at follow up testes

    1 year

Secondary Outcomes (4)

  • death from any cause

    1 year

  • cardiac death

    1 year

  • reinfarction

    1 year

  • target lesion revascularization

    1 year

Study Arms (1)

Study cohort

All comers patients with coronary artery disease treated with percutaneous coronary intervention and at least one Biomime stent

Device: percutaneous coronary intervention

Interventions

percutaneous coronary interventionDEVICE

percutaneous coronary angioplasty with implantation of at least one Biomime stent

Also known as: Biomime stent
Study cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All comers patients with coronary artery disease treated with percutaneous coronary intervention and a Biomime stent, age \> 18 years

You may qualify if:

  • any coronary artery disease treated with percutaneous coronary intervention and a Biomime stent

You may not qualify if:

  • patients \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Maggiore della Carita

Novara, Piedmont, 28100, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Alessandro Lupi, MD

    Azienda Ospedaliero Universitaria Maggiore della Carita

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Lupi, MD

CONTACT

+3903213733236lupialessandro1@tin.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Alessandro Lupi

Study Record Dates

First Submitted

March 22, 2015

First Posted

March 26, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

IT(1)