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

Primary Purpose

Ischemia, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EXCEL-Ⅱ
Sponsored by
JW Medical Systems Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia focused on measuring MACE, TVR, MI, TLF, Death

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18yrs≤Age≤75yrs .
  2. De novo lesion at native coronary artery.
  3. Single target vessel and single target lesion.
  4. Lesion length ≤32mm.
  5. RVD 2.5mm～4.0mm.
  6. DS%≥70% by visual estimation.
  7. Target lesion could be covered by only one stent.
  8. Subjects are willing to follow the specified requirements follow-up.
  9. 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:

  1. AMI within one week.
  2. CTO(TIMI0),LM lesion,ostial lesion,graft vessel lesion,bifurcation (side branch RVD≥2.5mm),ISR,mutivessel disease need to be treated.
  3. Severe calcified lesion unable to predilate.
  4. extremely tortuous proximal to the lesion that is inadequate to stent delivery.
  5. NYHA≥Ⅲ or LVEF≤40%.
  6. Prior stenting within 1 year.
  7. Pregnancy or lactation, and plan in postoperative pregnancy or lactation.
  8. 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.
  9. 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).
  10. To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
  11. Serious liver and kidney function is not complete person.
  12. The investigators think that do not fit to enroll the study.

Sites / Locations

  • Shenyang Northern Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EXCEL-Ⅱ

Arm Description

A new Cobalt ChRomium Alloys Sirolimus Eluting BioDegradable Polymer Stent In the Treatment of Patients with de novo Coronary Artery Lesions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary endpoint
In-stent Late Lumen Loss at 4-month and 12-month

Full Information

First Posted
February 5, 2013
Last Updated
April 25, 2023
Sponsor
JW Medical Systems Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01909869
Brief Title
A Pilot First In Man Study of EXCEL-Ⅱto Treat the Patients With de Novo Coronary Artery Lesions
Acronym
CREDIT
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
June 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Medical Systems Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia, Coronary Artery Disease
Keywords
MACE, TVR, MI, TLF, Death

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EXCEL-Ⅱ
Arm Type
Experimental
Arm Description
A new Cobalt ChRomium Alloys Sirolimus Eluting BioDegradable Polymer Stent In the Treatment of Patients with de novo Coronary Artery Lesions.
Intervention Type
Device
Intervention Name(s)
EXCEL-Ⅱ
Other Intervention Name(s)
CREDIT-Ⅰ
Intervention Description
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
Primary Outcome Measure Information:
Title
Primary endpoint(MACE)
Description
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
Time Frame
30days(MACE)
Secondary Outcome Measure Information:
Title
Secondary endpoint
Description
In-stent Late Lumen Loss at 4-month and 12-month
Time Frame
5 years (Follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han y ling, PhD
Organizational Affiliation
Shenyang Northern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenyang Northern Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110015
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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