PREPARE:Assessing the Safety and Efficacy of Radial Versus Femoral Approach PCI

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
Medtronic
CCRF Consulting Co., Ltd.
Information provided by (Responsible Party):
Yuejing Yang, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01735110
First received: November 23, 2012
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of TRI versus TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery disease.


Condition Intervention
Transradial-transfemoral Coronary Interventions Comparison
Procedure: transfemoral intervention (TFI)
Procedure: Transradial intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized Trial Assessing the Safety and Efficacy of PCI Via Radial Versus Femoral Approach in Patients With Left Main and/or Three-Vessel Disease

Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • major adverse cardiac and cerebrovascular events (MACCE) at 12 months [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The primary endpoint is the major adverse cardiac and cerebrovascular events (MACCE) defined as the composite of all-caused death, all stroke, all myocardial infarction (MI), or any revascularization at 12 months.


Secondary Outcome Measures:
  • The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    - The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure


Other Outcome Measures:
  • Other outcomes [ Time Frame: 5years ] [ Designated as safety issue: Yes ]
    • Death (Cardiac, Vascular, Non-cardiovascular)
    • MI
    • Stroke
    • TLR (Ischemia-driven, not ischemia-driven) at 12 months
    • TVR (Ischemia-driven, not ischemia-driven) at 12 months
    • Stent thrombosis (per ARC definition) at 12 months
    • Minor bleeding complication (BARC type 1 or 2) at 7 and 30 days
    • Total bleeding complication (BARC definition) at 7 and 30 days
    • PCI procedural success
    • Device success
    • Procedural or fluoro time
    • Cross lesion failure rate
    • Total procedure time
    • Total amount of contrast use
    • Total radiation doses
    • Major vascular access site complication at discharge and 30 days post-procedure


Enrollment: 0
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Femoral approach group
PCI through Femoral approach
Procedure: transfemoral intervention (TFI)
Experimental: radial approach group
PCI through radial approach
Procedure: Transradial intervention

Detailed Description:

Transradial intervention (TRI) has been widely practiced in China, accounting for approximate 80 to 90% of procedures. A recent meta-analysis indicated that TRI has advantages in reducing major bleeding and ischemic events compared to transfemoral intervention (TFI) after the percutaneous coronary intervention (PCI). However, no clinical trial has yet shown statistical equivalence in terms of long-term efficacy of TRI compared with TFI for the treatment of complex coronary lesions, which is simply due to limited numbers of subjects enrolled. The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of TRI versus TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery disease.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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 written 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.
  • Patient with complex lesion who may need two or more than 2 stents implantation during the indexed procedure is required surgeon's consultation before the operation. The surgical consultation outcome must be recorded in detail.
  • 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.

Angiographic inclusion criteria:

  • Target lesion must be able to be treated by using six-French guiding catheters.
  • Target lesion can be Left Main and/or Multivessel Diseases with Syntax score ≤32 for LM and Syntax score ≤22 for MVD.

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.
  • Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. Human Immunodeficiency Virus, Lupus etc. Not include diabetes mellitus).
  • Known hypersensitivity or contraindication to aspirin, zotarolimus, polymer, Nickel, cobalt, chromium, iron, tungsten, etc. or stainless steel.
  • Patient has extensive peripheral vascular disease that precludes safely insertion of 6 French sheath.
  • 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.
  • STEMI within 72h prior to procedure.
  • History of CABG.
  • Radial artery or femoral artery presence serious vascular bend or deformity that the 6F sheath can not go though.
  • Based on investigator's clinical judgments, high-risk patients, referring to predicted procedural risks being higher than the procedural benefits must be excluded.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01735110

Sponsors and Collaborators
Cardiovascular Institute & Fuwai Hospital
Medtronic
CCRF Consulting Co., Ltd.
Investigators
Principal Investigator: Yuejing Yang, Professor Fuwai hospital
  More Information

No publications provided

Responsible Party: Yuejing Yang, Professor, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01735110     History of Changes
Other Study ID Numbers: PREPARE
Study First Received: November 23, 2012
Last Updated: December 11, 2013
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on August 21, 2014