NeoVas Bioresorbable Coronary Scaffold Registry Study

NCT02305472 | Unknown DMC

• 1 other identifier: LPM-201403
• Study Type: interventional
• Target: 825
• Locations: 1 country
• Sites: 27

Brief Summary

The NeoVas Bioresorbable Coronary Scaffold Registry Trial is a prospective, multi-center, single arm registry trial based on the NeoVas FIM study which verified the safety and effectiveness of NeoVas initially. This study is to evaluate the safety and effectiveness of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion.

Conditions

Coronary Artery Disease

Keywords

NeoVas; Bioresorbable Coronary Scaffold; Sirolimus; Registry Trial

Outcome Measures

Primary Outcomes (1)

• Target lesion failure

  Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.

  1 year

Secondary Outcomes (9)

• Device Success

  intraoperative

• Procedural Success

  At time of procedure up to 7 days in hospital

• Target lesion failure

  30days, 3,6,9 months and 2,3,4,5 years

• Patient oriented composite endpoint

  30days, 3,6,9 months and 1,2,3,4,5 years

• Ischemia-driven Target Lesion Revascularization (iTLR)

  30 days, 3,6,9 months and 1, 2, 3, 4, 5 years

Study Arms (1)

NeoVas BCS

EXPERIMENTAL

The NeoVas sirolimus-eluting bioresorbable coronary scaffold system is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.

Device: NeoVas BCS

Interventions

NeoVas BCS DEVICE

Subjects receiving NeoVas BCS

Also known as: NeoVas Bioresorbable Coronary Scaffold

NeoVas BCS

Eligibility Criteria

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

You may qualify if:

• 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.
• Patients with one or two de novo lesions located in different epicardial vessels.
• Target lesion must be≤20mm in length(visual estimation)and 2.75 to 3.75 mm in diameter(Online QCA).
• 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.

You may not qualify if:

• Patients has had a known diagnosis of acute myocardial infarction(AMI) within 7 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.

Sponsors & Collaborators

• Lepu Medical Technology (Beijing) Co., Ltd.: lead

Study Sites (27)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

General Hospital of Armed Police Forces

Beijing, Beijing Municipality, 100039, China

Location

Aerospace Center Hospital

Beijing, Beijing Municipality, 100049, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Bethune Peace Hospital of PLA

Shijiazhuang, Hebei, 050081, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Wuhan General Hospital of Guangzhou Military

Wuhan, Hubei, 430070, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

The general hospital of Shenyang military region

Shenyang, Liaoning, 110016, China

Location

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200001, China

Location

Shanghai Tenth People'S Hospital of Tongji University

Shanghai, Shanghai Municipality, 200072, China

Location

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, 200433, China

Location

Xijing Hospital, the Fourth Military Medical University

Xi’an, Shanxi, 710032, China

Location

The First Affiliated Hospital of Xi'An Jiaotong University

Xi’an, Shanxi, 710061, China

Location

Chengdu Military General Hospital

Chengdu, Sichuan, 610083, China

Location

Affiliated Hospital of The Chinese People's Armed Police Forces Logistic College

Tianjin, Tianjin Municipality, 300162, China

Location

Tianjin first center hospital

Tianjin, Tianjin Municipality, 300192, China

Location

Kunming General Hospital of Chengdu Military Region

Kunming, Yunnan, 650032, China

Location

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Yaling Han, MD

  The general hospital of Shenyang military region

  STUDY CHAIR

• Guosheng Fu

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Bo Xu

  Beijing Fuwai hospital, National center for cardiovascular diseases China

  PRINCIPAL INVESTIGATOR

• Yao-Jun Zhang

  Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 2, 2014
• Study Start: November 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2020
• Last Updated: March 9, 2017

Record last verified: 2015-12

Locations

CN (27)