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

Transradial-transfemoral Coronary Interventions Comparison Clinical Trial

— PREPARE  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01735110
• Other study ID #: PREPARE
• Status: Withdrawn
• Phase: N/A
• First received: November 23, 2012
• Last updated: December 11, 2013
• Start date: March 2013
• Est. completion date: March 2018

Study information

• Verified date: December 2013
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Transradial-transfemoral Coronary Interventions Comparison

Intervention

Procedure:
• transfemoral intervention (TFI)

• Transradial intervention

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	CCRF Consulting Co., Ltd., Medtronic

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes