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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 Primeâ„¢ EES, in order to evaluate the efficacy and safety of the SES drug eluting stent in the treatment of coronary artery disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Abbott Xience Primeâ„¢ 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 Primeâ„¢). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Stent | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria-Clinical
Inclusion Criteria-Angiographic
Exclusion Criteria-Clinical
Exclusion Criteria-Angiographic
Target lesion is located within a saphenous vein graft or arterial graft.
Target lesion has any of the following characteristics:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 Oil Field Hospital | Principal Investigator |
| Ye Zhu | West China Hospital | Principal Investigator |
| Guosheng Fu |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Beijing | Beijing Municipality | 100032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16534015 | Result | 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. | |
| 32268942 |
| Label | URL |
|---|---|
| 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 | View source |
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recruitment period: July 2015 - September 2016 totally 11 investigational sites(hospitals) in China
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| ID | Title | Description |
|---|---|---|
| FG000 | Abbott Xience Primeâ„¢ 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 Primeâ„¢). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The subjects have been randomized and implanted with Abbott Xience Primeâ„¢ EES or BIOTRONIK Orsiro SES
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| ID | Title | Description |
|---|---|---|
| BG000 | Abbott Xience Primeâ„¢ 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 Primeâ„¢). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | There were 220 subjects who conducted the procedure in each group. | Posted | Mean | Standard Deviation | mm | At 9 months post procedure |
|
At 5 years post-procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). Coronary Stent |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Yuejin Yang | Fuwai Hospital | 008613701151408 | yangyjfw@126.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2015 | Oct 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| At 5 years post-procedure |
| Number of Participants With All-cause Death | The MACEs in the test group included 6 cases of all-cause death.Among them:
| At 5 years post-procedure |
| Number of Participants With Cardiac Death | Two subjects with Cardica death in test group:
| At 5 years post-procedure |
| 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. | At 5 years post-procedure |
| Number of Participants With TVR Myocardial Infarction | Target vessel-related myocardial infarction | At 5 years post-procedure |
| 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. | At 5 years post-procedure |
| Number of Participants With TLR | Target lesion revascularization | At 5 years post-procedure |
| Sir Run Run Shaw Hospital |
| Principal Investigator |
| Biao Xu | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| 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. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Abbott Xience Primeâ„¢ EES |
Patients implanted with Xience Primeâ„¢ EES stents of Abbot Laboratories |
|
|
| Secondary | 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. | There were 216 subjects who conducted the procedure and finished the 5 years following up in each group. | Posted | Count of Participants | Participants | At 5 years post-procedure |
|
|
|
| Secondary | Number of Participants With All-cause Death | The MACEs in the test group included 6 cases of all-cause death.Among them:
| There were 216 subjects who conducted the procedure and finished the 5 years following up in each group. | Posted | Count of Participants | Participants | At 5 years post-procedure |
|
|
|
| Secondary | Number of Participants With Cardiac Death | Two subjects with Cardica death in test group:
| There were 216 subjects who conducted the procedure and finished the 5 years following up in each group. | Posted | Count of Participants | Participants | At 5 years post-procedure |
|
|
|
| Secondary | 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. | 220 patients were enrolled in the each group. 5 patients died in the test group, and there was no myocardial infarction during the 5-year follow-up, and 4 patients were lost 5 follow-up. excluding these patients, the analysis population of the test group was 211. 6 patients died in the test group, and there was no myocardial infarction during the 5-year follow-up, and 4 patients were lost 5 follow-up. excluding these patients, the analysis population of the test group was 210. | Posted | Count of Participants | Participants | At 5 years post-procedure |
|
|
|
| Secondary | Number of Participants With TVR Myocardial Infarction | Target vessel-related myocardial infarction | 4 subjects lost contact in each group at 5 years of follow-up. In the test group, 5 subjects dead, and no happened TVR myocardial infarction, Except for these subjects, the analysis population of the test group is 211. In the control group, 6 subjects dead, and no happened TVR myocardial infarction. Except for these subjects, the analysis population of the control group is 210. | Posted | Count of Participants | Participants | At 5 years post-procedure |
|
|
|
| Secondary | 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. | 4 subjects lost contact in each group at 5 years of follow-up. In the test group, 5 subjects dead, and no happened In-stent thrombus, Except for these subjects, the analysis population of the test group is 211. In the control group, 6 subjects dead, and no happened In-stent thrombus. Except for these subjects, the analysis population of the control group is 210. | Posted | Count of Participants | Participants | At 5 years post-procedure |
|
|
|
| Secondary | Number of Participants With TLR | Target lesion revascularization | 4 subjects lost contact in each group at 5 years of follow-up. In the test group, 5 subjects dead, and no happened TLR, Except for these subjects, the analysis population of the test group is 211. In the control group, 6 subjects dead, and no happened TLR. Except for these subjects, the analysis population of the control group is 210. | Posted | Count of Participants | Participants | At 5 years post-procedure |
|
|
|
| 6 |
| 216 |
| 82 |
| 216 |
| 148 |
| 216 |
| EG001 | Abbott Xience Primeâ„¢ 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 Primeâ„¢). Coronary Stent | 6 | 216 | 79 | 216 | 141 | 216 |
| Type 2 diabetic patient | Gastrointestinal disorders | Systematic Assessment |
|
| Coronary heart disease | Cardiac disorders | Systematic Assessment |
|
| Cerebral infarction | Vascular disorders | Systematic Assessment |
|
| Gastric diseases | Gastrointestinal disorders | Systematic Assessment | Including gastric carcinoma, gastrorrhagia, gastroesophageal reflux, gastric ulcer, gastritis, gastrointestinal bleeding, etc... |
|
| Target lesion revascularization | Cardiac disorders | Systematic Assessment |
|
| Target vessel revascularization | Cardiac disorders | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | Systematic Assessment |
|
| Pulmonary infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Non-target vessel revascularization | Cardiac disorders | Systematic Assessment |
|
| Unstable angina pectoris | Cardiac disorders | Systematic Assessment |
|
| MI(myocardial infarction) | Cardiac disorders | Systematic Assessment |
|
| Post- PCI | Cardiac disorders | Systematic Assessment |
|
| Bosom frowsty chest pain | General disorders | Systematic Assessment |
|
| Heart related diseases | Cardiac disorders | Systematic Assessment | Including: Acute non-ST elevation myocardial infarction Exertional angina Old myocardial infarction arrhythmology Angina pectoris Heart failure Cardiac death Precardiac discomfort Cardiac insufficiency Atrial flutter Atrial tachycardia |
|
| Kidney related diseases | Renal and urinary disorders | Systematic Assessment |
|
| Other diseases | General disorders | Systematic Assessment |
|
| Dental related diseases | Musculoskeletal and connective tissue disorders | Systematic Assessment | Including: Bleeding gums Gingival bleeding epistaxis periodontitis Tooth mobility Periapical periodontitis Periodontal abscess |
|
| Type 2 diabetic patient | Gastrointestinal disorders | Systematic Assessment |
|
| Coronary heart disease | Cardiac disorders | Systematic Assessment |
|
| Cerebral infarction | Vascular disorders | Systematic Assessment |
|
| Gastric diseases | Gastrointestinal disorders | Systematic Assessment | Including: gastritis Gastric ulcer Chronic gastritis The gastric mucosa is congested Upset stomach Chronic non-atrophic gastritis with erosion Acute gastroenteritis |
|
| Chest tightness of chest pain | General disorders | Systematic Assessment |
|
| Troponin is elevated | Cardiac disorders | Systematic Assessment |
|
| hypohepatia | Hepatobiliary disorders | Systematic Assessment |
|
| Post-PCI | Cardiac disorders | Systematic Assessment |
|
| Have a headache giddy | General disorders | Systematic Assessment |
|
| unstable angina pectoris | Cardiac disorders | Systematic Assessment |
|
| Hypertension | Blood and lymphatic system disorders | Systematic Assessment |
|
| Heart related diseases | Cardiac disorders | Systematic Assessment | Including: The cause of palpitations is unknown Atrial tachycardia Stable angina pectoris tachycardia Sinus bradycardia Exertional angina Cardiac insufficiency arrhythmology |
|
| Kidney related diseases | Renal and urinary disorders | Systematic Assessment | Including: Blood in the urine hyperuricemia The cause of the painful urine is unknown Urinary tract infection The left kidney cyst Renal insufficiency Ureteral calculi prostatitis Left renal cyst prostatic hyperplasia |
|
| Other diseases | General disorders | Systematic Assessment | Mainly Including: High blood pressure esophagitis Room sex premature beat Lower blood pressure Allergic dermatitis Left knee joint trauma tenosynovitis upper respiratory tract infection (URTI) Gastrointestinal bleeding Subcutaneous bleeding |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D019060 | Minimally Invasive Surgical Procedures |