Status:
COMPLETED
A Pilot First In Man Study of EXCEL-Ⅱto Treat the Patients With de Novo Coronary Artery Lesions
Lead Sponsor:
JW Medical Systems Ltd
Conditions:
Ischemia
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
One of the purpose of this study is to assess the preliminary safety and feasibility,and to provide related information and evidence for the design of the further pivotal randomized control trial.the ...
Detailed Description
1. Single-center, prospective, pilot study 2. De novo,coronary artery, single vessel and single lesion 3. Sample size = 45 4. Follow- up clinical or phone at 1-month,9-month and annually 2 to 5 years ...
Eligibility Criteria
Inclusion
- 18yrs≤Age≤75yrs .
- De novo lesion at native coronary artery.
- Single target vessel and single target lesion.
- Lesion length ≤32mm.
- RVD 2.5mm～4.0mm.
- DS%≥70% by visual estimation.
- Target lesion could be covered by only one stent.
- Subjects are willing to follow the specified requirements follow-up.
- A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
Exclusion
- AMI within one week.
- CTO(TIMI0),LM lesion,ostial lesion,graft vessel lesion,bifurcation (side branch RVD≥2.5mm),ISR,mutivessel disease need to be treated.
- Severe calcified lesion unable to predilate.
- extremely tortuous proximal to the lesion that is inadequate to stent delivery.
- NYHA≥Ⅲ or LVEF≤40%.
- Prior stenting within 1 year.
- Pregnancy or lactation, and plan in postoperative pregnancy or lactation.
- Subjects had bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue DAPT healers at least 1 year.
- There are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (\< 1 year).
- To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
- Serious liver and kidney function is not complete person.
- The investigators think that do not fit to enroll the study.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2019
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01909869
Start Date
January 1 2013
End Date
June 4 2019
Last Update
April 26 2023
Active Locations (1)
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1
Shenyang Northern Hospital
Shenyang, Liaoning, China, 110015