Biomime Stent in All-comers PCI Patients Registry

NCT ID: NCT02398955

Last Updated: 2015-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Study cohort

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

percutaneous coronary intervention

Intervention Type DEVICE

percutaneous coronary angioplasty with implantation of at least one Biomime stent

Interventions

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percutaneous coronary intervention

percutaneous coronary angioplasty with implantation of at least one Biomime stent

Intervention Type DEVICE

Other Intervention Names

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Biomime stent

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients \<18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role lead

Responsible Party

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Lupi Alessandro

Dr Alessandro Lupi

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandro Lupi, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero Universitaria Maggiore della Carita

Locations

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Azienda Ospedaliero Universitaria Maggiore della Carita

Novara, Piedmont, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandro Lupi, MD

Role: CONTACT

+3903213733236

Facility Contacts

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Alessandro Lupi, M.D.

Role: primary

+393495643838

Other Identifiers

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BELLINI01

Identifier Type: -

Identifier Source: org_study_id

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