BIOFLOW-III Hungary Satellite Registry

• ClinicalTrials.gov Identifier: NCT01892917
• Recruitment Status: Terminated
• First Posted: July 8, 2013
• Last Update Posted: October 12, 2017
• Sponsor: Biotronik Hungária Kft.
• Information provided by (Responsible Party): Biotronik Hungária Kft.

Tracking Information

• First Submitted Date: July 2, 2013
• First Posted Date: July 8, 2013
• Last Update Posted Date: October 12, 2017
• Actual Study Start Date: September 2012
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 2, 2013)

Target Lesion Failure (TLF) [ Time Frame: 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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 11, 2017)

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

Original Secondary Outcome Measures (submitted: July 2, 2013)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: BIOFLOW-III Hungary Satellite Registry
• 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 Hungary
• 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 Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

Condition

• Coronary Artery Disease
• Myocardial Ischemia

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 2, 2013): 2000
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 31, 2016
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hungary

Administrative Information

• NCT Number: NCT01892917
• Other Study ID Numbers: G1217
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Biotronik Hungária Kft.
• Study Sponsor: Biotronik Hungária Kft.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Béla Merkely, Prof.; Semmelweis University

• PRS Account: Biotronik Hungária Kft.
• Verification Date: October 2017