BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - V
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Biotronik, Inc.
- Enrollment
- 1334
- Primary Endpoint
- Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent system.
Detailed Description
The BIOTRONIK BIOFLOW-V clinical trial is a prospective, multicenter, randomized, controlled trial combining data on the randomized subjects with data from two historical studies by employing a Bayesian approach. Subjects with CAD that qualify for PCI with stenting will be screened per the protocol inclusion and exclusion criteria to achieve a total of up to 1,400 randomized subjects. Eligible subjects will be randomized in a 2:1 ratio, stratified by study center, to undergo percutaneous coronary revascularization with either the Orsiro Sirolimus Eluting Stent System (treatment group) or the Xience Everolimus Eluting Stent System (control group). Subjects may receive treatment of up to three target lesions, one or two target lesions per target vessel, for a maximum of two target vessels. The target lesion(s) must be de novo or restenotic lesion(s) of ≤ 36 mm in length in native coronary artery(ies), with a reference vessel diameter of 2.25-4.0 mm. Treatment of restenotic lesions is allowed provided that the target lesion was previously treated with PTCA only. All treatment with study stents is to be performed during a single index procedure. Note: Concurrent treatment of non-target lesions during the index procedure is not allowed. Randomized subjects will have clinical follow-up at 1 month, 6 months, 12 months and at 2, 3, 4 and 5 years following the index procedure. To assess the non-inferiority of the Orsiro stent compared to the Xience stent, BIOFLOW-V randomized subjects will be combined with historical subjects from the BIOFLOW-II and BIOFLOW-IV randomized trials employing a Bayesian approach. Only subjects who meet all clinical and angiographic eligibility criteria of the BIOFLOW-V trial will be included in the analysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is ≥18 years or the minimum age required for legal adult consent in the country of enrollment.
- •Subject is an acceptable candidate for PCI.
- •Subject is an acceptable candidate for CABG.
- •Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
- •Subject is eligible for dual anti-platelet therapy treatment with aspirin plus either, clopidogrel, prasugrel, ticagrelor or ticlopidine.
- •Subject has provided written informed consent.
- •Subject is willing to comply with study follow-up requirements.
- •Each target lesion/vessel must meet all of the following angiographic criteria for the subject to be eligible for the trial:
- •Subject has up to three target lesions in up to two separate target vessels (two target lesions in one vessel and one target lesion in a separate vessel).
- •Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.
Exclusion Criteria
- •Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
- •Subject is hemodynamically unstable.
- •Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
- •Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), acrylic, fluoropolymers, silicon carbide, PLLA, sirolimus or everolimus.
- •Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure.
- •Planned treatment of a lesion not meeting angiographic inclusion and exclusion criteria during the index procedure or after the index procedure.
- •Planned surgery within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period.
- •History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
- •Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
- •Subject will refuse blood transfusions.
Outcomes
Primary Outcomes
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation
Time Frame: 12-Months
TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
Secondary Outcomes
- Number of Lesions With Device Success(Hospital Discharge (6-24 hours post-index procedure))
- Number of Lesions With Lesion Success(Hospital Discharge (6-24 hours post-index procedure))
- Number of Participants With Procedure Success(Hospital Discharge (6-24 hours post-index procedure))
- Number of Participants With Myocardial Infarction or Cardiac Death(Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years)
- Number of Participants With MACE and Individual MACE Components(Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years)
- Number of Participants With TLF and Individual TLF Components(Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years)
- Number of Participants With Myocardial Infarction(Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years)
- Number of Participants With Stent Thrombosis(24 hours, 30 days, 1 year, and 5 years post-index procedure)
- Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components(Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years)