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BIOFLOW-III UK Satellite Registry Orsiro Stent System

NCT ID: NCT02257710

Last Updated: 2017-10-02

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

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-12-31

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.

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 neointimal 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. It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

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

All subjects requiring coronary revascularization with Drug Eluting Stents (DES)

Orsiro

Intervention Type DEVICE

Interventions

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Orsiro

Intervention Type DEVICE

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 for data release
* 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

Sponsors

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Biotronik UK Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Mahmoudi, MD

Role: PRINCIPAL_INVESTIGATOR

St. Peter's Hospital

Locations

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Royal Sussex County Hospital

Brighton, East-Sussex, United Kingdom

Site Status RECRUITING

St Peter's Hospital

Chertsey, Surrey, United Kingdom

Site Status RECRUITING

University Hospital Southampton

Southampton, , United Kingdom

Site Status RECRUITING

Royal Cornwall Hospital

Truro, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Marcus Knott

Role: CONTACT

[email protected]
+44 (0) 7970084632

Facility Contacts

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David Hildick-Smith, MD

Role: primary

+441273696955 ext. 4049

Michael Mahmoudi, MD

Role: primary

+44 1932 872000

Michael Mahmoudi

Role: primary

Trevor Johnston, Dr.

Role: primary

Other Identifiers

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G1402

Identifier Type: -

Identifier Source: org_study_id