A Pilot First In Man Study of EXCEL-Ⅱto Treat the Patient... | NCT01909869

Studies
A Pilot First In Man Study of EXCEL-Ⅱto Treat the Patients With de Novo Coronary Artery Lesions

NCT01909869

Sponsor

JW Medical Systems Ltd

Status

Completed

Last Update Posted

Apr 26, 2023Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Ischemia
Coronary Artery Disease

Interventions

EXCEL-Ⅱ

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013Actual

Primary Completion Date

Sep 2013Actual

Completion Date

Jun 4, 2019Actual

First Submitted Date

Feb 5, 2013

First Submission Date that Met QC Criteria

Jul 24, 2013

First Posted Date

Jul 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2023

Last Update Posted Date

Apr 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EXCEL-Ⅱ	Experimental	A new Cobalt ChRomium Alloys Sirolimus Eluting BioDegradable Polymer Stent In the Treatment of Patients with de novo Coronary Artery Lesions.	Device: EXCEL-Ⅱ

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EXCEL-Ⅱ	Device	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	30days(MACE)

Secondary Outcomes

Measure	Description	Time Frame
Secondary endpoint	In-stent Late Lumen Loss at 4-month and 12-month	5 years (Follow-up)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D003327	Coronary Disease
D017202	Myocardial Ischemia