Trials Sponsors Conditions Drugs Pricing

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 interventionProcedure

radial approach group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

CCRF Consulting Co., Ltd.
Othercollaborator
Medtronic
Industrycollaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Study Officials

Yuejing Yang, Professor
Chinese Academy of Medical Sciences, Fuwai Hospital
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

Femoral approach group

radial approach group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

Femoral approach group

radial approach group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record