Trial record 2 of 19 for:    bioflow biotronik

BIOTRONIK Orsiro Pre-Marketing Registration (BIOFLOW-VI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Biotronik (Beijing) Medical Device Ltd.
Sponsor:
Information provided by (Responsible Party):
Biotronik (Beijing) Medical Device Ltd.
ClinicalTrials.gov Identifier:
NCT02870985
First received: August 5, 2016
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease
Device: Coronary Stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biotronik (Beijing) Medical Device Ltd.:

Primary Outcome Measures:
  • In-stent late lumen loss at 9 months as assessed by the core laboratory QCA analysis [ Time Frame: at 9 months post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause death, Cardiac death, MI and Major adverse cardiac event assessed clinically. [ Time Frame: at 1, 6, and 12 months post-procedure, and once annually for up to 5 years ] [ Designated as safety issue: Yes ]
  • MI of the target vessel/Stent thrombosis/TLR/TVR/TLF/TVF assessed by coronary angiography. [ Time Frame: at 1, 6, and 12 months post-procedure, and once annually for up to 5 years ] [ Designated as safety issue: Yes ]
  • Serious adverse event related to device according to the SAE definitions. [ Time Frame: at 1, 6, and 12 months post-procedure, and once annually for up to 5 years ] [ Designated as safety issue: Yes ]
  • In-segment late lumen loss assessed by the core laboratory QCA analysis [ Time Frame: at 9 months post procedure ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment minimum lumen diameter assessed by the core laboratory QCA analysis [ Time Frame: at 9 months post procedure ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment binary restenosis rate assessed by the core laboratory QCA analysis [ Time Frame: at 9 months post procedure ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment percent diameter stenosis assessed by the core laboratory QCA analysis [ Time Frame: at 9 months post procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 440
Study Start Date: July 2015
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: percutaneous coronary intervention

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02870985

Contacts
Contact: Lan Chen +86 13811648209 lan.chen@biotronik.com

Locations
China, Beijing
Fuwai Hospital Recruiting
Beijing, Beijing, China, 100032
Contact: Yuejin Yang    +86 13701151408      
Sponsors and Collaborators
Biotronik (Beijing) Medical Device Ltd.
Investigators
Principal Investigator: Yuejin Yang Fuwai Hospital
Principal Investigator: Jing Xu Tianjin Chest Hospital
Principal Investigator: Yongde Wang TEDA International Cardiovascular 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: Yong Xu Teaching Hospital of Chengdu University of T.C.M.
Principal Investigator: Hui Li Daqing oilfield general hospital
Principal Investigator: Ye Zhu West China Hospital
Principal Investigator: Guosheng Fu Sir Run Run Shaw Hospital
Principal Investigator: Biao Xu Nanjing Drum Tower Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Biotronik (Beijing) Medical Device Ltd.
ClinicalTrials.gov Identifier: NCT02870985     History of Changes
Other Study ID Numbers: C1207 
Study First Received: August 5, 2016
Last Updated: August 17, 2016
Health Authority: China: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Isosorbide Dinitrate
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 22, 2016