- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01909869
A Pilot First In Man Study of EXCEL-Ⅱto Treat the Patients With de Novo Coronary Artery Lesions (CREDIT)
April 25, 2023 updated by: JW Medical Systems Ltd
A PILOT First-In-Man Study to Evaluate Safety and Efficacy of the EXCEL-Ⅱ With Cobalt Chromium Alloys Sirolimus Eluting Biodegradable Polymer Stent in the Treatment of Patients With de Novo Coronary Artery Lesions(CREDIT-I)
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
other purpose is to assess the performace of the stent delivery system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Single-center, prospective, pilot study
- De novo,coronary artery, single vessel and single lesion
- Sample size = 45
- Follow- up clinical or phone at 1-month,9-month and annually 2 to 5 years
- Randomization 2:1 Angio and OCT scheduled follow-up in the hospital
- Follow-up Angio and OCT randomized 30 patients for 4-month and 15 patiens for 12-month
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110015
- Shenyang Northern Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EXCEL-Ⅱ
A new Cobalt ChRomium Alloys Sirolimus Eluting BioDegradable Polymer Stent In the Treatment of Patients with de novo Coronary Artery Lesions.
|
A PILOT First-In-Man Study to evaluate safety and efficacy of the EXCEL-Ⅱ with New Cobalt ChRomium Alloys Sirolimus Eluting BioDegradable Polymer Stent In the Treatment of Patients with de novo Coronary Artery Lesions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary endpoint(MACE)
Time Frame: 30days(MACE)
|
Device oriented cardiovascular endpoint at 30-day (MACE) defined as the composite of Cardiac Death,Myocardial Infarction(Q and non-Q) or Ischemia-driven Target Lesion Revascularization
|
30days(MACE)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary endpoint
Time Frame: 5 years (Follow-up)
|
In-stent Late Lumen Loss at 4-month and 12-month
|
5 years (Follow-up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Han y ling, PhD, Shenyang Northern Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
June 4, 2019
Study Registration Dates
First Submitted
February 5, 2013
First Submitted That Met QC Criteria
July 24, 2013
First Posted (Estimate)
July 29, 2013
Study Record Updates
Last Update Posted (Actual)
April 26, 2023
Last Update Submitted That Met QC Criteria
April 25, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2012-12
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 Ischemia
-
Beytepe Murat Erdi Eker State HospitalCompletedAnterior Segment Ischemia (Diagnosis)
-
University Hospital, Strasbourg, FranceTerminatedVascular Surgery | Ischemia-reperfusion | Ischemia PreconditioningFrance
-
University Hospital, Strasbourg, FranceCompletedSkeletal Muscle Ischemia | Severe Lower Limb Ischemia | Mitochondrial DysfunctionFrance
-
Egyptian Cerebro-Cardio-Vascular AssociationUnknownRisk Factor, Cardiovascular | Ischemia, Myocardial | Ischemia, Cerebral
-
Technische Universität DresdenRecruitingRetinal IschemiaGermany
-
Centre Hospitalier Universitaire de NiceCompleted
-
Attikon HospitalUniversity Hospital of PatrasCompleted
-
Beth Israel Deaconess Medical CenterWithdrawn
-
Groupe Hospitalier Paris Saint JosephCompleted
-
Hospices Civils de LyonCompleted
Clinical Trials on EXCEL-Ⅱ
-
Genrix (Shanghai) Biopharmaceutical Co., Ltd.RecruitingLupus Erythematosus, SystemicChina
-
Xijing HospitalUnknown
-
JW Medical Systems LtdCompletedMyocardial Ischemia | Heart Diseases | Cardiovascular Diseases | Vascular Diseases | Coronary Artery Disease | Coronary Disease | Arteriosclerosis | Arterial Occlusive DiseasesChina
-
Suzhou Alphamab Co., Ltd.Recruiting
-
University of Texas Southwestern Medical CenterIntegra LifeSciences CorporationCompleted
-
BrosMed Medical Co., LtdCCRF Inc., Beijing, ChinaUnknownArteriovenous FistulaChina
-
Guangdong Provincial Hospital of Traditional Chinese...RecruitingSiewert Type II Adenocarcinoma of Esophagogastric Junction | Esophagogastric Junction AdenocarcinomaChina
-
University Hospital, CaenNot yet recruitingContact Lens ComplicationFrance
-
Cutera Inc.CompletedSkin Pigment | PhotoagingUnited States