BIOFLOW III Satellite-Italy Orsiro Stent System

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

COMPLETED

Total Enrollment

609 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-07-31

Brief Summary

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Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry. The sample size maybe increased in order to reach the subgroup sizes (Diabetes, small vessel, AMI and CTO).

Detailed Description

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For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neontimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.

Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the collection of clinical evidence for the clinical Performance.

Conditions

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Coronary Artery Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Orsiro

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Symptomatic coronary artery disease
* Subject signed informed consent for data release
* Subject is geographically stable and willing to participate at all follow up assessments
* Subject is ≥ 18 years of age

Exclusion Criteria

* Subject did not sign informed consent
* Pregnancy
* Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
* Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
* Currently participating in another study and primary endpoint not reached yet

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martina Del Maestro

Role: STUDY_DIRECTOR

BIOTRONIK ITALIA SPA

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G1307

Identifier Type: -

Identifier Source: org_study_id

BIOFLOW III Satellite-Italy Orsiro Stent System

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Orsiro

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Biotronik Italia S.p.A.

Responsible Party

Principal Investigators

Martina Del Maestro

Locations

Ospedale Sant'Anna

Cardiologia Ospedaliera Policlinico Bari

Cardiologia Universitaria Policlinico Bari

Clinical Santa Maria

Ospedale Di Venere

Policlinico Conzorciale di Bari

P.O. Cardarelli

Azienda Ospedaliera Pugliese-Ciaccio

Ospedale F. Veneziale

A.O. Ospedale Civile Legnano

AO Ospedale Civile Legnano, Fornaroli, Magenta

Centro Cardiologico Monzino

Istituto Clinico Città Studi, Milano

Clinica Mediterranea

Ospedale San Salvatore AORMN

European Hospital

Casa Sollievo della Sofferenza

Clinical Villa Verde

Countries

Other Identifiers

G1307