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

NCT01735110 | Withdrawn DMC

• 1 other identifier: PREPARE
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Transradial-transfemoral Coronary Interventions Comparison

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Outcomes (1)

• Other outcomes

  5years

Study Arms (2)

Femoral approach group

ACTIVE COMPARATOR

PCI through Femoral approach

Procedure: transfemoral intervention (TFI)

radial approach group

EXPERIMENTAL

PCI through radial approach

Procedure: Transradial intervention

Interventions

transfemoral intervention (TFI) PROCEDURE

Femoral approach group

Transradial intervention PROCEDURE

radial approach group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• Medtronic: collaborator
• CCRF Consulting Co., Ltd.: collaborator

Study Officials

• Yuejing Yang, Professor

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: November 28, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2018
• Last Updated: December 12, 2013

Record last verified: 2013-12