- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02868203
OCT Based Edge and In-stent Vascular Response After Cordimax Stent in patIents With NSTE-ACS
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)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: ling tao, doctor
- Phone Number: 86-29-84775183
- Email: lingtao@fmmu.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age ≥18 and ≤ 75 years
- Non-ST-segment elevation MI
- 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:
- 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
- Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up
- Calcified target lesion(s) which cannot be successfully predilated
- Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: OCT at 3 months
OCT at 3 months and 12 OCT at 3 months
|
OCT after stent implantation
|
Active Comparator: OCT at 6months
OCT at 6 months and 12 OCT at 3 months
|
OCT after stent implantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of uncovered and/or malapposed bioDegradable polymer sIrolimus-eLuting stent at 12 month after the implant, as measured by OCT
Time Frame: 12 month
|
12 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ky20162025-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Angina, Unstable
-
Korea University Anam HospitalCompletedDiabetic Stable Angina | Diabetic Unstable AnginaKorea, Republic of
-
Gennaro SardellaUnknownNon ST Segment Elevation MI and Unstable AnginaItaly
-
Bon-Kwon KooSamsung Medical Center; Chonnam National University Hospital; Seoul National... and other collaboratorsCompleted
-
Ulsan University HospitalSeoul National University HospitalCompletedStable Angina | Unstable AnginaKorea, Republic of
-
University Hospital TuebingenAcrostakUnknownMyocardial Ischemia | Stable or Unstable Angina PectorisGermany
-
CID - Carbostent & Implantable DevicesCompletedStable Angina | Unstable Angina | NSTEMINetherlands, Italy
-
Medhub Ltd.CompletedStable Angina | Unstable Angina | NSTEMIIsrael
-
Ospedale San DonatoTerminatedStable Angina | Unstable AnginaItaly
-
Jun LiUnknown
-
Jun LiGuang'anmen Hospital of China Academy of Chinese Medical SciencesUnknown
Clinical Trials on OCT
-
Assiut UniversityNot yet recruitingProliferative Diabetic Retinopathy
-
University of ZurichUnknownGlaucoma | CataractSwitzerland
-
Vienna Institute for Research in Ocular SurgeryRecruiting
-
Careggi HospitalCompletedCoronary Artery | Stent Thrombosis | Platelet | ThrombusItaly
-
University Hospital Inselspital, BerneRecruitingGlaucoma | Macular Degeneration | Uveitis | Diabetic Retinopathy | Diabetic Macular Edema | Macular Edema | Retinal Vein Occlusion | Optic Nerve Diseases | Retinal Detachment | Macular Disease | Retinal Disease | Retinal Neovascularization | Retinal Artery Occlusion | Hypertensive Retinopathy | Retinal Edema | Retinal DystrophySwitzerland
-
Topcon Medical Systems, Inc.Completed
-
Topcon CorporationCompletedFluorescein Angiography ImagingUnited States
-
Centre Hospitalier Intercommunal CreteilWithdrawn