Clinical trial NCT01704911: Evaluate the Safety And Efficacy of the Transradial Coronary in Comparison With the Transfemoral Coronary Intervention
Official title: Determination of the Transradial Versus Transfemoral Coronary Angioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Free Rate of Cardiac or Cerebrovascular Events
Transradial-transfemoral Coronary Interventions Comparison
Keywords: Transradial
Transfemoral
Coronary Intervention
Lead sponsor: CCRF Consulting Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Terumo Medical (Shanghai) Co.,Ltd.
First posted: 2012-10-12
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: major adverse cardiac or cerebrovascular events free rate
timeFrame: one year
Secondary outcomes:
measure: the major bleeding complication (BARC definition type 3 or 5)-free rate
timeFrame: 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Shonan Kamakura General Hospital, Japan
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University First Hospital
name: Yong Huo, MD
role: PRINCIPAL_INVESTIGATOR
References: