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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Transradial-transfemoral Coronary Interventions Comparison
• Intervention / Treatment: Procedure: transfemoral intervention (TFI); 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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Femoral approach group; PCI through Femoral approach	Procedure: transfemoral intervention (TFI)
Experimental: radial approach group; PCI through radial approach	Procedure: Transradial intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major adverse cardiac and cerebrovascular events (MACCE) at 12 months	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure	- The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other outcomes	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	5years

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Collaborators: Medtronic; CCRF Consulting Co., Ltd.
• Investigators: Principal Investigator: Yuejing Yang, Professor, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: November 23, 2012
• First Submitted That Met QC Criteria: November 24, 2012
• First Posted (Estimate): November 28, 2012

Study Record Updates

• Last Update Posted (Estimate): December 12, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: PREPARE