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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02257710
Other study ID # G1402
Secondary ID
Status Recruiting
Phase N/A
First received October 2, 2014
Last updated September 28, 2017
Start date November 2015
Est. completion date December 2018

Study information

Verified date September 2017
Source Biotronik UK Ltd.
Contact Marcus Knott
Phone +44 (0) 7970084632
Email marcus.knott@biotronik.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Orsiro


Locations

Country Name City State
United Kingdom Royal Sussex County Hospital Brighton East-Sussex
United Kingdom St Peter's Hospital Chertsey Surrey
United Kingdom University Hospital Southampton Southampton
United Kingdom Royal Cornwall Hospital Truro

Sponsors (1)

Lead Sponsor Collaborator
Biotronik UK Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Target Lesion Failure (TLF) Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR) 12 months
Secondary TLF Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR) 6 months
Secondary Target Vessel Revascularization (TVR) Any repeat revascularization of the target vessel. 6 and 12 months
Secondary Target Lesion Revascularization (TLR) Defined as any repeat revascularization of the target lesion. 6 and 12 months
Secondary Stent Thrombosis Definite, Probable and Possible Stent Thrombosis 6 and 12 months
Secondary Clinical Device Success Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without use of a device outside the assigned treatment strategy. up to seven days
Secondary Clinical Procedural success Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event during the hospital stay to a maximum of the first seven days post index procedure. up to seven days
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