BIOTRONIK Orsiro Pre-Marketing Registration (BIOFLOW-VI)

August 3, 2023 updated by: Biotronik (Beijing) Medical Device Ltd.

BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With de Novo Coronary Artery Lesions-VI

The clinical investigation is a non-inferiority, multicenter, blinding evaluation, randomized, parallel controlled clinical study enrolling up to 440 subjects. All subjects will be randomized 1:1 to receive the BIOTRONIK Orsiro SES or the Abbott Xience Prime™ EES, in order to evaluate the efficacy and safety of the SES drug eluting stent in the treatment of coronary artery disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Clinical or call follow up visits will take place at 1, 6, 12, 24, 36, 48 and 60 months post procedure. At 9 months (+ 30 days) all subjects will undergo a standard quantitative coronary angiography (QCA) follow up to assess the in-stent LLL as the main efficacious evaluation. Use the major adverse cardiac event (death, myocardial infarction and stent thrombosis) within one year post procedure as the main safety indicators to evaluate the investigational product's safety. The clinical and angiographic data sorting, calculation and statistical analysis will be conducted by an independent data management center and angiographic core laboratory.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
440

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria-Clinical

  1. Subject who can understand the investigation's goal has provided written informed consent, and is willing to comply with the study's follow-up requirements.
  2. Subject is ≥ 18 years and ≤ 75 years old, male or female without pregnant.
  3. Subject is an acceptable candidate for PCI.
  4. Subject has clinical evidence of asymptomatic ischemia, stable or unstable angina pectoris or old myocardial infarction.
  5. Subject has no contraindication for dual anti-platelet therapy treatment.

Inclusion Criteria-Angiographic

  1. Target lesion must be in the major coronary artery or a branch (target vessel).
  2. Target lesion must have angiographic evidence of ≥ 70% and < 100% stenosis (by operator's visual estimate).
  3. Subject has up to two target lesions (two target lesions in one target vessel, or for each target vessel, it has one target lesion).
  4. Target lesion is suitable for drug-eluting stent PCI treatment.
  5. Target lesion must be ≤ 36 mm in length by operator's visual estimate, and can be completely covered by one stent.
  6. Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator's visual estimate.
  7. Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥ 2.

Exclusion Criteria-Clinical

  1. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
  2. Subject has clinical symptoms and/or ECG changes consistent with acute ST elevation MI (STEMI) within 7 days prior to the index procedure, including hemodynamically unstable non-STEMI (NSTEMI) subjects.
  3. Subject is hemodynamically unstable.
  4. Subject is an unacceptable candidate for CABG.
  5. 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.
  6. Previous revascularization of any target or non-target vessel 9 months prior to the index procedure.
  7. Planned surgery within 6 months of the index procedure.
  8. Planned staged treatment during the index procedure or within 30 days after the index procedure.
  9. History of a stroke or transient ischemic attack (TIA) within 12 months prior to the index procedure.
  10. Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
  11. Subject will refuse blood transfusions.
  12. Subject has documented severe cardiac failure (over III level of NYHA) or left ventricular ejection fraction (LVEF) ≤ 40% as evaluated by echocardiogram, left ventricular angiography, radionuclide ventriculography or any non-invasive imaging method within 90 days prior to the index procedure.
  13. Subject is dialysis-dependent.
  14. Subject has impaired renal function (i.e., creatinine > 2.0 mg/dL or 175 μmol/L determined) within 7 days prior to the index procedure.
  15. Subject has leukopenia (i.e. WBC < 3.5*10*9/L), thrombocytopenia (plt<100*10*9/L) or thrombocytosis (PLT>350*10*9/L).
  16. Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent).
  17. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are excluded), or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is excluded).
  18. Subject has a life expectancy of < 3 years.
  19. In the investigator's opinion, subject will not be able to comply with the follow-up requirements.
  20. Subject is participating in another (medical device or drug) clinical study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.

Exclusion Criteria-Angiographic

  1. Target lesion is located within a saphenous vein graft or arterial graft.

  2. Target lesion has any of the following characteristics:

    1. Lesion location is within the left main coronary artery, or within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
    2. Involves a side branch of > 2.5 mm in diameter. Note: Lesions within 3 mm of the origin of the right coronary artery may be treated.
  3. Target lesion is totally occluded (100% stenosis).
  4. Target vessel has angiographic evidence of thrombus.
  5. Target vessel/lesion is excessively tortuous/angulated or is severely calcified, preventing complete inflation of an angioplasty balloon.
  6. Target vessel was treated with brachytherapy at any time prior to the index procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BIOTRONIK Orsiro SES
Preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted. The procedure begins once percutaneous access has been made.Following intracoronary injection of nitroglycerin or isosorbide dinitrate, a baseline angiography of the target vessel must be performed according to the QCA corelab guidelines.The subjects randomized to the experimental arm will be implanted with BIOTRONIK sirolimus eluting coronary stent(Orsiro).
Device: Coronary Stent
Other Names:
  • percutaneous coronary intervention
Active Comparator: Abbott Xience Prime™ EES
Preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted. The procedure begins once percutaneous access has been made.Following intracoronary injection of nitroglycerin or isosorbide dinitrate, a baseline angiography of the target vessel must be performed according to the QCA corelab guidelines.The subjects randomized to the comparator arm will be implanted with Abbott everolimus eluting coronary stent(Xience Prime™).
Device: Coronary Stent
Other Names:
  • percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
In-stent Late Lumen Loss at 9 Months as Assessed by the Core Laboratory QCA Analysis
Time Frame: At 9 months post procedure

QCA data will be provided by an independent core laboratory. A separate report with descriptive statistics will be provided by the core laboratory in accordance with their guidelines.

For the primary endpoint, both the lesion and patient level analysis will be done for 9-month in-stent LLL. The analysis on patient level for FAS is considered as main analysis. Other analysis based on lesion level and/or PPS is only for supportive purposes.
At 9 months post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Main Adverse Cardiac Event (MACE)
Time Frame: At 5 years post-procedure

Main adverse cardiac event include all-cause death, Q wave or non-Q wave myocardial infarction and clinically driven TLR.

The comparison between the two treatment groups for the secondary endpoints will be presented by the same anaysis method as baseline characteristics.

The normally distributed quantitative variables will be compared by Student's t-test and the qualititative vairiables which are not normally distributed will be compared by using Wilcoxon sum-rank test.
At 5 years post-procedure
Number of Participants With All-cause Death
Time Frame: At 5 years post-procedure

The MACEs in the test group included 6 cases of all-cause death.Among them:

  1. One subject died from upper gastrointestinal hemorrhage, which had no obvious relation to the operation and device.
  2. Two subjects died from gastric cancer and COVID-19 complicated with respiratory failure respectively, which was unrelated to the operation and device.
  3. One subject died suddenly at home on Day 192 after the baseline operation, with the cause of death unknown.
  4. During the 3-year follow-up, subject family member told that he/she had ever been hospitalized for cardiac failure, but died after invalid rescue. The event was determined as cardiac death, of which the relationship with the operation and device cannot be determined.
  5. During the 3-year follow-up of another subject, his/her family member told that he/she had died. For which his/her family member was reluctant to provide relevant supporting documents, the relationship with the operation and device cannot be determined.
At 5 years post-procedure
Number of Participants With Cardiac Death
Time Frame: At 5 years post-procedure

Two subjects with Cardica death in test group:

  1. One of the patient died of sudden death at home, with the cause of death unknown.The patient participated in the trial on April 15, 2016. He/She was treated in local hospital for chest tightness and syncope in September 2016. He was considered to have rheumatic heart disease, heart failure and cardiogenic syncope. After treatment, he was improved and discharged from hospital and died in October 2016. The possibility of sudden cardiac death caused by ventricular arrhythmia cannot be excluded.
  2. During the 3-year follow-up of a subject, his/her family member told that he/she had ever been hospitalized for cardiac failure, but the subject eventually died after invalid rescue of cardiac failure. As the hospital did not have definite basis for acute myocardial infarction during the event. Therefore, the event was determined as cardiac death, of which the relationship with the operation and device cannot be determined.
At 5 years post-procedure
Number of Participants With Myocardial Infarction
Time Frame: At 5 years post-procedure

Including Q-wave and Non Q-wave myocardial infarction. The comparison between the two treatment groups for the secondary endpoints will be presented by the same anaysis method as baseline characteristics.

The normally distributed quantitative variables will be compared by Student's t-test and the qualititative vairiables which are not normally distributed will be compared by using Wilcoxon sum-rank test.
At 5 years post-procedure
Number of Participants With TVR Myocardial Infarction
Time Frame: At 5 years post-procedure
Target vessel-related myocardial infarction
At 5 years post-procedure
In-stent Thrombus
Time Frame: At 5 years post-procedure
During the 5-year clinical follow-up after baseline operation, one stent thrombosis event occurred in the test group. On July 21, 2016, the subject was implanted with the Orsiro Sirolimus-Eluting Coronary Stent System due to coronary heart disease. As the subject developed chest pain again, the coronary angiography reexamination was performed on March 22, 2019. During the operation, the OCT (optical coherence tomography) showed stent thrombosis in the right coronary artery, and then thrombus aspiration was performed. Investigators in the clinical trial center where the subject was enrolled believed that the stent thrombosis identified 972 days after the baseline operation belonged to very late stent thrombosis (VLST). The causes of its occurrence were considered to be related to the stent malapposition caused by insufficient stent expansion during the baseline operation and the possible platelet resistance of the subject.
At 5 years post-procedure
Number of Participants With TLR
Time Frame: At 5 years post-procedure
Target lesion revascularization
At 5 years post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik (Beijing) Medical Device Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuejin Yang, Fuwai Hospital
  • Principal Investigator: Jing Xu, Tianjin Chest Hospital
  • Principal Investigator: Yaling Han, General Hospital of Shenyang Military Region
  • Principal Investigator: Bo Yu, The Second Affiliated Hospital of Harbin Medical University
  • Principal Investigator: Dan Song, Wuhan Asian Heart Hospital
  • Principal Investigator: Hui Li, Daqing Oilfield General Hospital
  • Principal Investigator: Ye Zhu, West China Hospital
  • Principal Investigator: Biao Xu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Principal Investigator: Guosheng Fu, Sir Run Run Shaw Hospital
  • Principal Investigator: Jian Zhang, TEDA International Cardiovascular Hospital
  • Principal Investigator: Wen Xie, Teaching Hospital of Chengdu University of T.C.M.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C1207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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