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

NCT ID: NCT01735110

Last Updated: 2013-12-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2018-03-31

Brief Summary

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.

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.

Conditions

Transradial-transfemoral Coronary Interventions Comparison

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Femoral approach group

PCI through Femoral approach

Group Type: ACTIVE_COMPARATOR

transfemoral intervention (TFI)

Intervention Type: PROCEDURE

radial approach group

PCI through radial approach

Group Type: EXPERIMENTAL

Transradial intervention

Intervention Type: PROCEDURE

Interventions

transfemoral intervention (TFI)

Intervention Type: PROCEDURE

Transradial intervention

Intervention Type: PROCEDURE

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 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

CCRF Consulting Co., Ltd.

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yuejing Yang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuejing Yang, Professor

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Other Identifiers

PREPARE

Identifier Type: -

Identifier Source: org_study_id