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

NCT01909869 | Completed DMC

• 1 other identifier: H-2012-12
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia; Coronary Artery Disease

Keywords

MACE; TVR; MI; TLF; Death

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Secondary endpoint

  5 years (Follow-up)

Study Arms (1)

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

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

Also known as: CREDIT-Ⅰ

EXCEL-Ⅱ

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yrs≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JW Medical Systems Ltd: lead

Study Sites (1)

Shenyang Northern Hospital

Shenyang, Liaoning, 110015, China

Location

MeSH Terms

Conditions

Ischemia; Coronary Artery Disease; Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Han y ling, PhD

  Shenyang Northern Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: July 29, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: June 4, 2019
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

CN (1)