Transradial-transfemoral Coronary Interventions ComparisonPREPARENCT01735110
PREPARE：Assessing the Safety and Efficacy of Radial Versus Femoral Approach PCI
A study testing transfemoral intervention (TFI) and Transradial intervention in people with Transradial-transfemoral Coronary Interventions Comparison, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Transradial-transfemoral Coronary Interventions Comparison
- What is being tested?
- transfemoral intervention (TFI) and Transradial intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
About this study
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
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.
Read the 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.
- Being tested
- transfemoral intervention (TFI), Transradial intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transfemoral intervention (TFI)Procedure or surgery
Transradial interventionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Femoral approach group | Active comparator | PCI through Femoral approach Receives: Procedure: transfemoral intervention (TFI) |
| radial approach group | Experimental | PCI through radial approach Receives: Procedure: Transradial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2014 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transradial-transfemoral Coronary Interventions ComparisonStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, CCRF Consulting Co., Ltd.
- Responsible party
- Principal investigator, Yuejing Yang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Yuejing Yang, Professor, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735110
- Sponsor's protocol ID
- PREPARE
- Acronym
- PREPARE
- Status last verified
- Dec 2013
- First submitted
- 23 Nov 2012
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01735110
- Acronym / sponsor ID
- PREPARE / PREPARE
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- Medtronic, CCRF Consulting Co., Ltd.
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral approach group | Active comparator | Procedure: transfemoral intervention (TFI)PCI through Femoral approach |
| radial approach group | Experimental | Procedure: Transradial interventionPCI through radial approach |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transfemoral intervention (TFI) | Procedure or surgery | Femoral approach group |
| Transradial intervention | Procedure or surgery | radial approach group |
Primary outcome
major adverse cardiac and cerebrovascular events (MACCE) at 12 months
Time frame: 1 year
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 secondary outcome
The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuejing Yang, Professor principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing transfemoral intervention (TFI) and Transradial intervention in people with Transradial-transfemoral Coronary Interventions Comparison, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiac and cerebrovascular events (MACCE) at 12 months (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2013.