BIOFLOW-III Sweden Satellite Registry

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

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

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease

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 Type: Observational
• Enrollment (Actual): 406

Contacts and Locations

Study Locations

• Sweden
  • Falun, Sweden
    • Falun Lasarett
  • Halmstad, Sweden
    • Halmstad Hospital
  • Helsingborg, Sweden
    • Helsingborg Hospital
  • Karlstad, Sweden
    • Centralsjukhuset i Karlstad
  • Stockholm, Sweden
    • Danderyd University Hospital
  • Stockholm, Sweden, 11883
    • Hjärtmottagningen
  • Stockholm, Sweden
    • Karolinska University Hospitals (Huddinge/Solna)
  • Örebro, Sweden, 701 85
    • Kardiologiska Kliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Orsiro DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Target Vessel Revascularization (TVR)	Any repeat revascularization of the target vessel.	6 and 12 months
Target Lesion Revascularization (TLR)	Any repeat revascularization of the target lesion.	6 and 12 months
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
Stent Thrombosis	Definite, Probable, Possible Stent thrombosis	6 and 12 months

Collaborators and Investigators

• Sponsor: Biotronik ApS
• Investigators: Principal Investigator: Ole Froebert, MD, Kardiologiska Kliniken

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 15, 2012
• First Submitted That Met QC Criteria: August 15, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Actual): September 28, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Diabetes; Percutaneous Coronary Intervention; STEMI; Angina; Ischemia; International; NSTEMI; Multicenter; Observational registry; Orsiro Drug Eluting Stent (DES); Stenting; Treatment of Coronary Artery Disease; Coronary revascularization; Subgroups; Small Vessels
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
• Other Study ID Numbers: G1209