BIOFLOW-III Hungary Satellite Registry

Terminated

• Conditions: Coronary Artery Disease; Myocardial Ischemia

• Registration Number: NCT01892917
• Lead Sponsor: Biotronik Hungária Kft.

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: 2012-09
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-08
• Primary Completion: 2016-09
• Study Completion: 2016-12-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2000

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 Revascularization (TLR)	6, 12 and 18 months	Any repeat revascularization of the target lesion
Target Lesion Failure	6 and 18 months	Any target lesion
Target Vessel Revascularization (TVR)	6, 12 and 18 months	Any repeat revascularization of the target vessel
Stent Thrombosis	6, 12 and 18 months	Definite, possible and probable
Clinical Device Success	At time of intervention	Clinical Device Success
Clinical Procedural Success	During the hospital stay to a maximum of the first seven days post index procedure	Clinical Procedural Success

Trial Locations

Locations (13)

Állami Szívkórház (State Hospital for cardiology of Balatonfüred); 🇭🇺 Balatonfüred, Hungary

Gottsegen György Országos Kardiológiai Intézet (Gottsegen György Hungarian Institute of Cardiology); 🇭🇺 Budapest, Hungary

Bajcsy-Zsilinszky Kórház (Bajcsy-Zsilinszky Hospital); 🇭🇺 Budapest, Hungary

SE ÁOK Kardiológiai Központ (Semmelweis University, Heart Center); 🇭🇺 Budapest, Hungary

DEOEC, Kardiológiai Intézet ( Institute of Cardiology, University of Debrecen); 🇭🇺 Debrecen, Hungary

Kaposi Mór Oktató Kórház, Kardiológia (Kaposi Mór Teaching Hospital, Cardiology); 🇭🇺 Kaposvár, Hungary

Jósa András Kórház, Kardiológia (Jósa András Hospital, Department of Cardiology); 🇭🇺 Nyíregyháza, Hungary

PTE ÁOK Szívcentrum (University of Pécs, Faculty of Medicine, Heart Institute); 🇭🇺 Pécs, Hungary

Szentgyörgyi Albert Tudomány Egyetem, ÁOK, Kardiológia (University of Szeged, Albert Szent-Györgyi Clinical Center, Faculty Of Medicine, Second Department of Medicine and Cardiology Centre); 🇭🇺 Szeged, Hungary

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház, Kardiológia-Hemodinamika (Jász-Nagykun-Szolnok County, Hetényi Géza Hospital, Cardiology, Haemodynamics); 🇭🇺 Szolnok, Hungary

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