BIOFLOW-III Sweden Satellite Registry

Coronary Artery Disease Clinical Trial

Official title:

BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III Sweden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667003
• Other study ID #: G1209
• Status: Completed
• Phase: N/A
• First received: August 15, 2012
• Last updated: September 26, 2017
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: September 2017
• Source: Biotronik ApS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

Description:

For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to long-term complications range from rather immediate elastic recoil 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%-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%-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 immobilised 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 a 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. This observational registry 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: Completed
• Enrollment: 406
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic coronary artery disease

• Subject has signed informed consent for data release

• Subject is geographically stable and willing to participate at all follow-up assessments

• Subject is = 18 years

Exclusion Criteria:

• Subject did not sign informed consent for data release

• Pregnancy

• Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media

• Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained

• Currently participating in another study and primary endpoint is not reached yet.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia

Locations

Country	Name	City	State
Sweden	Falun Lasarett	Falun
Sweden	Halmstad Hospital	Halmstad
Sweden	Helsingborg Hospital	Helsingborg
Sweden	Centralsjukhuset i Karlstad	Karlstad
Sweden	Kardiologiska Kliniken	Örebro
Sweden	Danderyd University Hospital	Stockholm
Sweden	Hjärtmottagningen	Stockholm
Sweden	Karolinska University Hospitals (Huddinge/Solna)	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik ApS

Country where clinical trial is conducted

Sweden, 

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), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)	12 months
Secondary	Target Lesion Failure (TLF)	Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)	6 and 12 months
Secondary	Target Vessel Revascularization (TVR)	Any repeat revascularization of the target vessel.	6 and 12 months
Secondary	Target Lesion Revascularization (TLR)	Any repeat revascularization of the target lesion.	6 and 12 months
Secondary	Stent Thrombosis	Definite, Probable, 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 (this includes successful delivery and deployment of multiple overlapping stents) 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. Standard predilation catheters and post-dilation catheters (if applicable) may be used.	At time of intervention
Secondary	Clinical Procedural Success	Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents, if applicable) and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% of the target lesion as observed by visual estimate without using any adjunctive device* without the occurrence of ischemia-driven major adverse cardiac event (ID-MACE) during the hospital stay to a maximum of the first seven days post index procedure.	During the hospital stay to a maximum of the first seven days post index procedure