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Completed

NCT Number: NCT01909869

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenyang Northern Hospital

Shenyang, Liaoning, 110015, China

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: CREDIT-Ⅰ

Primary outcomes

  1. 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

Secondary outcomes

  1. Secondary endpoint

    Time frame: 5 years (Follow-up)

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

Sponsors and collaborators

Lead sponsor

JW Medical Systems Ltd

Industry

Registry information

Official study 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)

Acronym: CREDIT

Important dates

Study start
2013
Primary completion
2013
Study completion
2019
First posted
Jul 29, 2013
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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