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

Angina, Unstable Clinical Trial

Official title:

Optical Coherence tOmography Based Edge and In-stent Vascular Response After a Novel bioDegradable Polymer sIrolimus-eLuting Stent in patIents With Non-ST Elevation acuTe Coronary sYndrome (NSTE ACS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02868203
• Other study ID #: ky20162025-1
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 11, 2016
• Last updated: August 15, 2016
• Start date: August 2016
• Est. completion date: August 2020

Study information

• Verified date: May 2016
• Source: Xijing Hospital
• Contact: ling tao, doctor
• Phone: 86-29-84775183
• Email: lingtao[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

Major concerns were addressed to the delayed healing process of drug-eluting stents . To date no studies have detailed the in-vivo completeness of CordimaxTM stent coverage at different time points. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (neointima disomogeneity, acquired late incomplete strut apposition) at different time points following CordimaxTM stent implantation, in patients with non-ST elevation acute coronary syndrome . Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at different time points (3-6-12 Months)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2020
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. age =18 and = 75 years

2. Non-ST-segment elevation MI

3. Patient willing to comply with specified follow-up

5.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

Exclusion Criteria:

1. 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

2. Impaired renal function or on dialysis

3. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC<3,000 cells/mm3

4. Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated

5. Patient requires low molecular weight heparin (LMWH) treatment postprocedure or has received a dose of LMWH =8 hours prior to index procedure

6. Patient has received any organ transplant or is on a waiting list for any organ transplant;

7. 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)

8. 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

9. Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies

10. Patient presents with cardiogenic shock

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

12. Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study

13. Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up

14. Calcified target lesion(s) which cannot be successfully predilated

15. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Device:
• OCT
OCT after stent implantation
• eLuting stent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of uncovered and/or malapposed bioDegradable polymer sIrolimus-eLuting stent at 12 month after the implant, as measured by OCT		12 month	Yes