BIOFLOW-III Belgium Satellite Registry

Completed

• Conditions: Coronary Artery Disease; Myocardial Ischemia

• Registration Number: NCT01831336
• Lead Sponsor: Biotronik Belgium NV

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-15
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-26
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	12 months	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)

Secondary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	6 months	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)
Clinical Procedural Success	During the hospital stay to a maximum of the first seven days post index procedure	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.
Target Vessel Revascularization (TVR)	6 and 12 months	Any repeat revascularization of the target vessel.
Stent Thrombosis	6 and 12 months	Definite, Probable and Possible Stent Thrombosis
Target Lesion Revascularization (TLR)	6 and 12 months	Any repeat revascularization of the target lesion.
Clinical Device Success	At time of intervention	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.

Trial Locations

Locations (8)

UCL St. Luc; 🇧🇪 Bruxelles, Belgium

Brussels Heart Center; 🇧🇪 Brussels, Belgium

CHU Charleroi; 🇧🇪 Charleroi, Belgium

Grand Hopital de Charleroi Saint Joseph; 🇧🇪 Gilly, Belgium

CHR de la Citadelle; 🇧🇪 Liège, Belgium

CHU Liège; 🇧🇪 Liège, Belgium

Brussels Heart Center St Pierre; 🇧🇪 Ottignies, Belgium

UCL de Mont Godine; 🇧🇪 Yvoir, Belgium