IschemiaCREDITNCT01909869
A Pilot First In Man Study of EXCEL-Ⅱto Treat the Patients With de Novo Coronary Artery Lesions
A study testing EXCEL-Ⅱ in people with Ischemia and Coronary Artery Disease, run by JW Medical Systems Ltd at 1 site in China.
Trial 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 other purpose is to assess the performace of the stent delivery system. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemia, Coronary Artery Disease
- What is being tested?
- EXCEL-Ⅱ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to 4 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Ischemia, Coronary Artery Disease
- Being tested
- EXCEL-Ⅱ
- Keywords
- MACE, TVR, MI, TLF, Death
- Medical subject headings
- Ischemia, Coronary Artery Disease, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXCEL-ⅡDevice
Also called CREDIT-Ⅰ
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
| Study group | Role | What they receive |
|---|---|---|
| EXCEL-Ⅱ | Experimental | A new Cobalt ChRomium Alloys Sirolimus Eluting BioDegradable Polymer Stent In the Treatment of Patients with de novo Coronary Artery Lesions. Receives: Device: EXCEL-Ⅱ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint(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
Measured: 30days(MACE)
Secondary outcomes (1)
Secondary endpoint
In-stent Late Lumen Loss at 4-month and 12-month
Measured: 5 years (Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completion4 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Medical Systems Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Han y ling, PhD, Principal investigator, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909869
- Sponsor's protocol ID
- H-2012-12
- Acronym
- CREDIT
- Status last verified
- Apr 2023
- First submitted
- 5 Feb 2013
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01909869
- Acronym / sponsor ID
- CREDIT / H-2012-12
- Conditions
- Ischemia, Coronary Artery Disease
- Keywords
- MACE, TVR, MI, TLF, Death
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- JW Medical Systems LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2013 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXCEL-Ⅱ | Experimental | Device: EXCEL-ⅡA new Cobalt ChRomium Alloys Sirolimus Eluting BioDegradable Polymer Stent In the Treatment of Patients with de novo Coronary Artery Lesions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXCEL-ⅡAlso: CREDIT-ⅠA 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 | Device | EXCEL-Ⅱ |
Primary outcome
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
1 secondary outcome
Secondary endpoint
Time frame: 5 years (Follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
Related trials for Ischemia
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han y ling, PhD principal investigator
Shenyang Northern Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXCEL-Ⅱ in people with Ischemia and Coronary Artery Disease, run by JW Medical Systems Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint(MACE) (time frame: 30days(MACE)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.