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Evaluate the Safety And Efficacy of the Transradial Coronary in Comparison With the Transfemoral Coronary Intervention

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ClinicalTrials.gov Identifier: NCT01704911
Recruitment Status : Unknown
Verified October 2012 by CCRF Consulting Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : October 12, 2012
Last Update Posted : October 26, 2012
Sponsor:
Collaborators:
Peking University First Hospital
Terumo Medical(shanghai) Co.,Ltd.
Information provided by (Responsible Party):
CCRF Consulting Co., Ltd.

Brief Summary:
The purpose of the DRAGON clinical trial is to evaluate the safety and efficacy of the transradial coronary intervention (TRI) in comparison with the transfemoral coronary intervention (TFI).

Condition or disease Intervention/treatment Phase
Free Rate of Cardiac or Cerebrovascular Events Transradial-transfemoral Coronary Interventions Comparison Procedure: Transradial Coronary Intervention Procedure: Transfemoral Coronary Intervention Device: Coronary Stent System Not Applicable

Detailed Description:
Historically, performing PCI requires making an access to the peripheral arteries by an arterial puncture or cutting down. This may lead to the serious bleeding complications especially under the situation of dual antiplatelet therapy and/or potent anti-coagulation therapies. TRI is now widely accepted as the most promising alternative for TFI around the world. It is supposed to reduce the incidence of the serious bleeding complication during and after PCI, as well as the total medical cost. There have been several prospective randomized trials comparing the safety and efficacy between TRI and TFI, but none of them had enough power to show the statistically valid equivalence in the efficacy between TRI and TFI. In this study, investigators randomize approximately 1,700 patients into TRI or TFI. Investigators adopt the rate of major adverse cardiac events (MACCE) at 1 year as the primary efficacy endpoint for the study. Based on these rates at 1 year, the sample size for the non-inferiority analysis for the primary efficacy endpoint is calculated. Through this randomization trial, investigators can achieve the scientific evidence for the improved safety and equal efficacy of TRI compared to TFI. This trial has enough statistical power to draw the final conclusion in the debate between TRI and TFI.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determination of the Transradial Versus Transfemoral Coronary Angioplasty
Study Start Date : October 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: Transradial Coronary Intervention
Transradial Coronary Intervention
Procedure: Transradial Coronary Intervention
Device: Coronary Stent System
Any kind of coronary stent system

Experimental: Transfemoral Coronary Intervention
Transfemoral Coronary Intervention
Procedure: Transfemoral Coronary Intervention
Device: Coronary Stent System
Any kind of coronary stent system




Primary Outcome Measures :
  1. major adverse cardiac or cerebrovascular events free rate [ Time Frame: one year ]

Secondary Outcome Measures :
  1. the major bleeding complication (BARC definition type 3 or 5)-free rate [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be at least 18 years of age.
  • Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides signed informed consent prior to the randomization, as approved by the appropriate IEC.
  • Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia).
  • Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  • Allen test is required for suitable candidate.
  • Patient must agree to undergo all protocol-required follow-up examinations.
  • Patient must agree not to participate in any other clinical study within the duration of this trial.
  • Target lesion must be able to be treated by using six-French guiding catheters.
  • Target lesion can be de Novo or restenotic.
  • The target lesion can be stable or unstable.

Exclusion Criteria:

  • Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
  • Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure.
  • Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. Human Immunodeficiency Virus, Lupus etc.).
  • Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
  • Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
  • Female patients of childbearing potential who have refused a urine or blood pregnancy test (to be done within 7 days prior to index procedure), patients who are nursing at the time of index procedure and those patients who do not agree at the time of consent to use any approved form of birth control up to and including the follow-up at 1 year.
  • The target lesion is considered not to be treated by using six-French guiding catheters.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704911


Contacts
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Contact: Yong HUO, MD 861084059198 ext 8528 ybwang@ccrfmed.com

Locations
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China
Peking University First Hospital Not yet recruiting
Beijing, China, 100034
Contact: Yong Huo, MD    861084059198 ext 8528      
Sponsors and Collaborators
CCRF Consulting Co., Ltd.
Peking University First Hospital
Terumo Medical(shanghai) Co.,Ltd.
Investigators
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Principal Investigator: Shigeru Saito, MD Shonan Kamakura General Hospital, Japan
Principal Investigator: Yong Huo, MD Peking University First Hospital

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Responsible Party: CCRF Consulting Co., Ltd.
ClinicalTrials.gov Identifier: NCT01704911     History of Changes
Other Study ID Numbers: DRAGON
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012
Keywords provided by CCRF Consulting Co., Ltd.:
Transradial
Transfemoral
Coronary Intervention