BIOTRONIK Orsiro Pre-Marketing Registration

NCT02870985 | Completed Results DMC

• 1 other identifier: C1207
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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 SES drug eluting stent in the treatment of coronary artery disease.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (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.

  At 9 months post procedure

Secondary Outcomes (7)

• Number of Participants With Main Adverse Cardiac Event (MACE)

  At 5 years post-procedure

• Number of Participants With All-cause Death

  At 5 years post-procedure

• Number of Participants With Cardiac Death

  At 5 years post-procedure

• Number of Participants With Myocardial Infarction

  At 5 years post-procedure

• Number of Participants With TVR Myocardial Infarction

  At 5 years post-procedure

Study Arms (2)

BIOTRONIK Orsiro SES

EXPERIMENTAL

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

Abbott Xience Prime™ EES

ACTIVE COMPARATOR

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

Interventions

Coronary Stent DEVICE

Also known as: percutaneous coronary intervention

Abbott Xience Prime™ EES; BIOTRONIK Orsiro SES

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Biotronik (Beijing) Medical Device Ltd.: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (2)

• 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.

  PMID: 16534015 RESULT

• 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.

  PMID: 32268942 DERIVED

Related Links

• This link is a PubMed URL that allows you to view an article about the efficacy and safety of high-frequency stimulation in patients with atrial fibrillation: a randomized controlled trial. PubMed is a free resource that supports the search and retrieval

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Prof. Yuejin Yang
• Organization: Fuwai Hospital

yangyjfw@126.com

008613701151408

Study Officials

• Yuejin Yang

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

• Jing Xu

  Tianjin Chest Hospital

  PRINCIPAL INVESTIGATOR

• Jian Zhang

  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

• Wen Xie

  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

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 18, 2016
• Study Start: July 14, 2015
• Primary Completion: April 6, 2017
• Study Completion: December 1, 2021
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)