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NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02305485
Recruitment Status : Active, not recruiting
First Posted : December 2, 2014
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Lepu Medical Technology (Beijing) Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: NeoVas BCS Device: XIENCE PRIME EECSS Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : November 2014
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: NeoVas

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

Intervention: Device: NeoVas BCS

Device: NeoVas BCS
Subjects receiving NeoVas BCS
Other Name: NeoVas Bioresorbable Coronary Scaffold
Active Comparator: XIENCE PRIME
XIENCE PRIME Everolimus Eluting Coronary Stent System is a balloon expandable metallic platform stent manufactured from a flexible cobalt chromium alloy with a multicellular design and coated with a thin nonadhesive, durable, biocompatible acrylic, and fluorinated everolimus-releasing copolymer. Intervention: Device: XIENCE PRIME EECSS
Device: XIENCE PRIME EECSS
Subjects receiving XIENCE PRIME EECSS
Other Name: XIENCE PRIME Everolimus Eluting Coronary Stent System



Primary Outcome Measures :
  1. In-segment late lumen loss (LLL) [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Major secondary endpoint: Percentage of patients who experienced angina within 1 year [ Time Frame: From 7 days post-procedure to 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).

  2. Device Success [ Time Frame: intraoperative ]
    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.

  3. Procedural Success [ Time Frame: At time of procedure up to 7 days in hospital ]
    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.

  4. Target lesion failure(TLF) [ Time Frame: 30days, 3,6,9 months and 1,2,3,4,5 years ]
    Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.

  5. Ischemia-driven Target Lesion Revascularization (iTLR) [ Time Frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years ]
  6. Ischemia-driven Target Vessel Revascularization (iTVR) [ Time Frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years ]
  7. All coronary revascularization (PCI and CABG) [ Time Frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years ]
    percutaneous coronary intervention (PCI) coronary artery bypass graft (CABG)

  8. Scaffold thrombosis [ Time Frame: 30days, 3,6,9 months and 1, 2, 3, 4, 5 years ]
    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.

  9. Percentage of patients who experienced angina [ Time Frame: 30days, 3,6,9 months and 2, 3, 4, 5 years ]
    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).

  10. Patient oriented composite endpoint [ Time Frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years ]
    Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.


Other Outcome Measures:
  1. Primary Endpoint for the Subgroup Study: Changes of the average lumen diameter before and after the usage of nitroglycerin [ Time Frame: 3 years ]
  2. Secondary Endpoint for the Subgroup Study: Angiographic Endpoint(after the usage of nitroglycerin) [ Time Frame: Index procedure, 1 and 3 years ]
    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 (%).

  3. Secondary Endpoint for the Subgroup Study: OCT Endpoint (after the usage of nitroglycerin) [ Time Frame: Index procedure, 1 and 3 years ]
    Mean/minimal lumen area, mean/minimal stent area, average neointimal hyperplasia (NIH) area, proportion of covered struts, proportion of malapposed struts.

  4. Secondary Endpoint for the Subgroup Study: FFR Endpoint (after the usage of nitroglycerin): Late and very late FFR loss/changes [ Time Frame: 1 and 3 years ]
  5. Secondary Endpoint for Subgroup Study: FFR Endpoint (after the usage of nitroglycerin): Target lesion FFR [ Time Frame: post-procedure, 1 and 3 years ]


Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305485


  Show 27 Study Locations
Sponsors and Collaborators
Lepu Medical Technology (Beijing) Co., Ltd.
Investigators
Study Chair: Yaling Han, MD The general hospital of Shenyang military region
Principal Investigator: Guosheng Fu Sir Run Run Shaw Hospital
Principal Investigator: Bo Xu Beijing Fuwai hospital, National center for cardiovascular diseases China

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lepu Medical Technology (Beijing) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02305485     History of Changes
Other Study ID Numbers: LPM-201402
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by Lepu Medical Technology (Beijing) Co., Ltd.:
NeoVas
Bioresorbable Coronary Scaffold
Sirolimus
Randomized Controlled Trial

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents