NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial

Coronary Artery Disease Clinical Trial

Official title:

Clinical Evaluation of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients With Denovo Coronary Artery Lesion (NeoVas): Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02305485
• Other study ID #: LPM-201402
• Status: Active, not recruiting
• Phase: N/A
• First received: November 27, 2014
• Last updated: December 7, 2016
• Start date: November 2014
• Est. completion date: June 2020

Study information

• Verified date: December 2016
• Source: Lepu Medical Technology (Beijing) Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial is a prospective, multi-center, randomized trial. The study compares NeoVas sirolimus-eluting bioresorbable coronary scaffold with XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) to evaluate the safety and efficacy of NeoVas in the treatment of patients with de novo coronary lesion.

Description:

Approximately 560 subjects will be randomly enrolled at a 1:1 ratio, patients in experimental group receiving NeoVas BCS(Lepu Medical Technology (Beijing) Co.,Ltd), and subjects in control group receiving XIENCE PRIME EECSS(Abbott Vascular, Inc). Subjects will have clinical follow-up at 30, 90, 180 and 270 days and at 1,2,3,4 and 5 years. All subjects will undergo coronary angiography at 1 year post-index procedure. The primary endpoint is in-segment late lumen loss(LLL) at 1 year follow-up.

Among the RCT study, a subgroup study is designed to evaluate the functional recovery of vasomotion before and after the complete degradation of the NeoVas Bioresorbable Coronary Scaffold with the aid of angiography, OCT and FFR. The subgroup study will be performed in two centers and 160 subjects will be enrolled on a 1:1 randomization basis. Subjects will receive angiography and OCT examination before procedure, and will receive angiography, OCT and FFR after procedure and at 1, 3 years follow-up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 560
• Est. completion date: June 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age must be 18-75 years, men or unpregnant women.

• Patient must have evidence of myocardial ischemia, suitable for elective PCI. Subjects with stable angina or silent ischemia and <70% diameter stenosis must have objective sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG. In the absence of noninvasive ischemia, fractional flow reserve(FFR) must be done and indicative of ischemia.

• Total number of target lesion =1 per patient.

• Target lesion must be=20mm in length and 2.50 to 3.75 mm in diameter(visual estimation).

• Target lesion is with a visually estimated stenosis of =70%(or=50% and evidence of myocardial ischemia) with a TIMI flow of =1.

• The target lesion can be covered by one scaffold(except the rescue scaffold).

• Patient must be an acceptable candidate for coronary artery bypass graft.

• Patient or a legally authorized representative must provide written Informed Consent prior to any study related procedure.

Exclusion Criteria:

• Patients has had a known diagnosis of acute myocardial infarction(AMI) within 30 days preceding the procedure; CK and CK-MB have not returned within normal limits at the time of procedure

• Chronic total occlusion lesions (TIMI 0 grade blood flow prior to implantation), left trunk vessel lesion, ostial lesion, multi-branch lesions needing treated, bifurcation lesion (diameter =2.0mm, branch opening stenosis exceeds 50% or need balloon expansion) and bridge vessel lesions; there is thrombus visible in the target blood vessels.

• Severe calcified lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents.

• In-stent restenosis lesion.

• Patient has undergone previous stenting anywhere within the target vessel(s) within the previous 12 months, or will require stenting within the target vessel(s) within 1 year after the study procedure; target vessels that has been implanted with stents.

• Severe heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)<40%( supersonic inspection or left ventricular radiography ).

• Known renal insufficiency(eGFR<60 ml/min, serum creatinine>2.5mg/dL, or subject on dialysis).

• Patients with hemorrhage tendency, an active digestive ulcer history, a cerebral hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a year, and these patients who contraindicate against platelet inhibitors and anticoagulant therefore cannot bear anticoagulation treatment.

• Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticagrelor or prasugrel, heparin, contrast agent, polylactic acid or sirolimus that cannot be adequately pre-medicated.

• Life expectancy < 12 months

• Patient is participating in another device or drug study that has not reached the primary endpoint of the study.

• Patient's inability to fully cooperate with the study protocol.

• Patient has a heart transplant.

• Patient has current unstable arrhythmias, such as high risk ventricular premature beat and ventricular tachycardia.

• Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure.

• Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease.

• Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, warfarin).

• Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin, clopidogrel, ticagrelor or prasugrel.

• Platelet count<100,000 cells/mm3 or>700,000 cells/mm3, a WBC of<3,000 cells/mm3, or documented or suspected liver disease.

• Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• NeoVas BCS
Subjects receiving NeoVas BCS
• XIENCE PRIME EECSS
Subjects receiving XIENCE PRIME EECSS

Locations

Country	Name	City	State
China	Aerospace Center Hospital	Beijing	Beijing
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	General Hospital of Armed Police Forces	Beijing	Beijing
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Chengdu Military General Hospital	Chengdu	Sichuan
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Nanfang Hospital Southern Medical University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Kunming General Hospital of Chengdu Military Region	Kunming	Yunnan
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Changhai Hospital of Shanghai	Shanghai	Shanghai
China	Renji Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai Tenth People'S Hospital of Tongji University	Shanghai	Shanghai
China	The general hospital of Shenyang military region	Shenyang	Liaoning
China	Bethune Peace Hospital of PLA	Shijiazhuang	Hebei
China	Affiliated Hospital of The Chinese People's Armed Police Forces Logistic College	Tianjin	Tianjin
China	Tianjin first center hospital	Tianjin	Tianjin
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Wuhan General Hospital of Guangzhou Military	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'An Jiaotong University	Xi'an	Shanxi
China	Xijing Hospital, the Fourth Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Lepu Medical Technology (Beijing) Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Primary Endpoint for the Subgroup Study: Changes of the average lumen diameter before and after the usage of nitroglycerin		3 years	No
Other	Secondary Endpoint for the Subgroup Study: Angiographic Endpoint(after the usage of nitroglycerin)	In-segment, in-scaffold, 5mm proximal and 5mm distal Late and very late lumen loss (mm); In-segment, in-scaffold, 5mm proximal and 5mm distal Minimal lumen diameter(mm); In-segment, in-scaffold, 5mm proximal and 5mm distal Diameter stenosis (%);In-segment, in-scaffold, 5mm proximal and 5mm distal Angiographic Binary Restenosis (%).	Index procedure, 1 and 3 years	No
Other	Secondary Endpoint for the Subgroup Study: OCT Endpoint (after the usage of nitroglycerin)	Mean/minimal lumen area, mean/minimal stent area, average neointimal hyperplasia (NIH) area, proportion of covered struts, proportion of malapposed struts.	Index procedure, 1 and 3 years	No
Other	Secondary Endpoint for the Subgroup Study: FFR Endpoint (after the usage of nitroglycerin): Late and very late FFR loss/changes		1 and 3 years	No
Other	Secondary Endpoint for Subgroup Study: FFR Endpoint (after the usage of nitroglycerin): Target lesion FFR		post-procedure, 1 and 3 years	No
Primary	In-segment late lumen loss (LLL)	In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold and 5 mm proximal and 5 mm distal to the scaffold from post-procedure to 1 year by angiography.	1 year	Yes
Secondary	Major secondary endpoint: Percentage of patients who experienced angina within 1 year	Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).	From 7 days post-procedure to 1 year	Yes
Secondary	Device Success	Successful delivery and deployment of the assigned scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). The success or failure of the first-aid stent is not included.	intraoperative	Yes
Secondary	Procedural Success	Achievement of final in-scaffold residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned scaffold at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR. For the circumstance of two target lesions, both lesions must meet the success criteria.	At time of procedure up to 7 days in hospital	Yes
Secondary	Target lesion failure(TLF)	Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.	30days, 3,6,9 months and 1,2,3,4,5 years	Yes
Secondary	Ischemia-driven Target Lesion Revascularization (iTLR)		30 days, 3,6,9 months and 1, 2, 3, 4, 5 years	Yes
Secondary	Ischemia-driven Target Vessel Revascularization (iTVR)		30 days, 3,6,9 months and 1, 2, 3, 4, 5 years	Yes
Secondary	All coronary revascularization (PCI and CABG)	percutaneous coronary intervention (PCI) coronary artery bypass graft (CABG)	30 days, 3,6,9 months and 1, 2, 3, 4, 5 years	Yes
Secondary	Scaffold thrombosis	Scaffold thrombosis will be categorized as acute (=1day), subacute (>1day =30 days) and late (>30 days).Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion).In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days.	30days, 3,6,9 months and 1, 2, 3, 4, 5 years	Yes
Secondary	Percentage of patients who experienced angina	Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).	30days, 3,6,9 months and 2, 3, 4, 5 years	Yes
Secondary	Patient oriented composite endpoint	Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.	30 days, 3,6,9 months and 1, 2, 3, 4, 5 years	Yes