OCT Based Edge and In-stent Vascular Response After Cordimax Stent in patIents With NSTE-ACS

NCT02868203 | Unknown Phase 4 DMC

• 1 other identifier: ky20162025-1
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the completeness of strut coverage and vessel wall response, at different time points (3-6-12 Months), following CordimaxTM stent implantation in patients with non-ST elevation acute coronary syndrome

Conditions

Angina, Unstable; Non-ST-Segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Proportion of uncovered and/or malapposed bioDegradable polymer sIrolimus-eLuting stent at 12 month after the implant, as measured by OCT

  12 month

Study Arms (2)

OCT at 3 months

ACTIVE COMPARATOR

OCT at 3 months and 12 OCT at 3 months

Device: OCT; Device: eLuting stent

OCT at 6months

ACTIVE COMPARATOR

OCT at 6 months and 12 OCT at 3 months

Device: OCT; Device: eLuting stent

Interventions

OCT DEVICE

OCT after stent implantation

OCT at 3 months; OCT at 6months

eLuting stent DEVICE

OCT at 3 months; OCT at 6months

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 ≥18 and ≤ 75 years
• Non-ST-segment elevation MI
• Patient willing to comply with specified follow-up
• Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent 6.Single or two de novo or non-stented restenotic lesion in a native coronary artery 7. Target lesion to be covered by a single stent of max 30 mm . Reference vessel diameter ≥2.25 to ≤ 4.0 mm by visual estimate 8. The vessel diameter should be measured after pre-dilation procedure and after intra-coronary nitroglycerin if spasm is suspected 9. Target lesion ≥70% stenosed by visual estimate

You may not qualify if:

• Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test
• Impaired renal function or on dialysis
• Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a WBC\<3,000 cells/mm3
• Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
• Patient requires low molecular weight heparin (LMWH) treatment postprocedure or has received a dose of LMWH ≤8 hours prior to index procedure
• Patient has received any organ transplant or is on a waiting list for any organ transplant;
• Patient has other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (\<1 year)
• Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, sirolimus and/or contrast sensitivity that cannot be adequately pre-medicated
• Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies
• Patient presents with cardiogenic shock
• Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion;
• Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
• Calcified target lesion(s) which cannot be successfully predilated
• Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Angina, Unstable

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Central Study Contacts

ling tao, doctor

CONTACT

86-29-84775183; lingtao@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2020
• Last Updated: August 16, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share