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Coronary Artery DiseaseBIOFLOW-VINCT02870985

BIOTRONIK Orsiro Pre-Marketing Registration

A study testing Coronary Stent in people with Coronary Artery Disease, run by Biotronik (Beijing) Medical Device Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Coronary Stent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
1 siteChina
Study dates
14 Jul 2015to Dec 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Subject is ≥ 18 years and ≤ 75 years old, male or female without pregnant.
  • Subject is an acceptable candidate for PCI.
  • Subject has clinical evidence of asymptomatic ischemia, stable or unstable angina pectoris or old myocardial infarction.
  • Subject has no contraindication for dual anti-platelet therapy treatment.
  • Target lesion must be in the major coronary artery or a branch (target vessel).
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  • Target lesion must have angiographic evidence of ≥ 70% and < 100% stenosis (by operator's visual estimate).
  • Subject has up to two target lesions (two target lesions in one target vessel, or for each target vessel, it has one target lesion).
  • Target lesion is suitable for drug-eluting stent PCI treatment.
  • Target lesion must be ≤ 36 mm in length by operator's visual estimate, and can be completely covered by one stent.
  • Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator's visual estimate.
  • Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥ 2.

Who cannot join

  • Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
  • 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.
  • Subject is hemodynamically unstable.
  • Subject is an unacceptable candidate for CABG.
  • 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.
  • Previous revascularization of any target or non-target vessel 9 months prior to the index procedure.
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  • Planned surgery within 6 months of the index procedure.
  • Planned staged treatment during the index procedure or within 30 days after the index procedure.
  • History of a stroke or transient ischemic attack (TIA) within 12 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.
  • 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.
  • Subject is dialysis-dependent.
  • 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.
  • Subject has leukopenia (i.e. WBC < 3.5*10*9/L), thrombocytopenia (plt<100*10*9/L) or thrombocytosis (PLT>350*10*9/L).
  • Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent).
  • 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).
  • Subject has a life expectancy of < 3 years.
  • In the investigator's opinion, subject will not be able to comply with the follow-up requirements.
  • 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.
  • Target lesion is located within a saphenous vein graft or arterial graft.
  • Target lesion has any of the following characteristics:
  • 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).
  • 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.
  • Target lesion is totally occluded (100% stenosis).
  • Target vessel has angiographic evidence of thrombus.
  • Target vessel/lesion is excessively tortuous/angulated or is severely calcified, preventing complete inflation of an angioplasty balloon.
  • Target vessel was treated with brachytherapy at any time prior to the index procedure.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai Hospital

    Beijing, Beijing Municipality, 100032

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Coronary Stent
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary StentDevice

    Also called percutaneous coronary intervention

Study groups in NCT02870985
Study groupRoleWhat they receive
BIOTRONIK Orsiro SESExperimentalPreparation 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).
Receives: Device: Coronary Stent
Abbott Xience Prime™ EESActive comparatorPreparation 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™).
Receives: Device: Coronary Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-stent Late Lumen Loss at 9 Months as Assessed by the Core Laboratory QCA Analysis

    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.

    Measured: At 9 months post procedure

Secondary outcomes (7)

  1. Number of Participants With Main Adverse Cardiac Event (MACE)

    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.

    Measured: At 5 years post-procedure

  2. Number of Participants With All-cause Death

    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.

    Measured: At 5 years post-procedure

  3. Number of Participants With Cardiac Death

    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.

    Measured: At 5 years post-procedure

  4. Number of Participants With Myocardial Infarction

    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.

    Measured: At 5 years post-procedure

  5. Number of Participants With TVR Myocardial Infarction

    Target vessel-related myocardial infarction

    Measured: At 5 years post-procedure

  6. In-stent Thrombus

    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.

    Measured: At 5 years post-procedure

  7. Number of Participants With TLR

    Target lesion revascularization

    Measured: At 5 years post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2016 (estimated)
  2. Study start14 Jul 2015
  3. Primary completion6 Apr 2017
  4. Study completionDec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02870985
Sponsor's protocol ID
C1207
Acronym
BIOFLOW-VI
Status last verified
Aug 2023
First submitted
5 Aug 2016
Last updated
4 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Urban P, Gershlick AH, Guagliumi G, Guyon P, Lotan C, Schofer J, Seth A, Sousa JE, Wijns W, Berge C, Deme M, Stoll HP; e-Cypher Investigators. Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry. Circulation. 2006 Mar 21;113(11):1434-41. doi: 10.1161/CIRCULATIONAHA.104.532242. Epub 2006 Mar 13.

    PubMed 16534015

  • Li C, Yang Y, Han Y, Song D, Xu J, Guan C, Gao R, Garcia-Garcia HM, Waksman R, Xu B; BIOFLOW VI Trial Investigators. Comparison of the Ultrathin Strut, Biodegradable Polymer Sirolimus-eluting Stent With a Durable Polymer Everolimus-eluting Stent in a Chinese Population: The Randomized BIOFLOW VI Trial. Clin Ther. 2020 Apr;42(4):649-660.e9. doi: 10.1016/j.clinthera.2020.02.014. Epub 2020 Apr 5.

    PubMed 32268942

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Stent in people with Coronary Artery Disease, run by Biotronik (Beijing) Medical Device Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent Late Lumen Loss at 9 Months as Assessed by the Core Laboratory QCA Analysis (time frame: At 9 months post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02870985, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.

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BIOTRONIK Orsiro Pre-Marketing Registration | AzTrials