Percutaneous Coronary InterventionSAFE-PCINCT01406236
SAFE-PCI for Women
A study testing Transradial PCI and Transfemoral PCI in people with Percutaneous Coronary Intervention and Ischemic Symptoms, run by Duke University.
Trial summary
The hypothesis of the SAFE-PCI for women trial is that, compared with transfemoral PCI, transradial PCI will result in a significant reduction in bleeding and vascular complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Percutaneous Coronary Intervention, Ischemic Symptoms
- What is being tested?
- Transradial PCI and Transfemoral PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,787 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Sep 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have the capacity to understand and sign an informed consent form
- Age ≥ 18 years
- Female patient undergoing urgent or elective PCI or undergoing diagnostic angiography to evaluate ischemic symptoms with the possibility of PCI
Who cannot join
- Peripheral arterial disease that prohibits vascular access
- Bilateral abnormal Barbeau tests
- Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (note that the opposite arm may be used for radial access in case a dialysis graft is present in one arm provided that the opposite arm has a normal Barbeau test)
- International normalized ratio (INR) ≥ 1.5 in a patient treated with oral vitamin K antagonists (i.e., warfarin).
- Receipt of oral Factor Xa or IIa inhibitors ≤ 24 hours prior to the procedure
- Planned staged PCI within 30 days of index procedure
Show all 12Show fewer
- Valvular heart disease requiring valve surgery
- Planned right-heart catheterization
- Primary PCI for ST-segment elevation myocardial infarction
- Presence of bilateral internal mammary artery coronary bypass grafts
- Unable to provide informed consent
- Participation in any investigational drug or device study currently or within 30 days prior to enrollment
About this study
Official title: Study of Access Site for Enhancement of PCI for Women (SAFE-PCI for Women)
The hypothesis of the SAFE-PCI for women trial is that, compared with transfemoral PCI, transradial PCI will result in a significant reduction in bleeding and vascular complications. The primary objective is to compare the efficacy and feasibility of the transradial approach to percutaneous coronary intervention (PCI) in women compared with the transfemoral approach.
This study is a multicenter, randomized, open-label active controlled study. Three thousand women undergoing urgent or elective PCI from at least 50 centers will be randomized to either transradial or transfemoral PCI. Patients who are enrolled at sites performing ad hoc PCI will be randomized before diagnostic angiography. A total of approximately 3000 women will be randomized to obtain a cohort of approximately 1800 patients undergoing PCI.
The Data Safety Monitoring Board has alerted us that the bleeding event rate overall in our trial is very low, making it unlikely that there will be statistical power to show a difference between the randomized arms in the SAFE PCI for Women study using the BARC bleeding definition per protocol. Based on this statistical futility, the DSMB has recommended stopping enrollment. They also noted, however, that as this is not based on any safety issues, and since there are a variety of key secondary endpoints (contrast and radiation exposure, quality of life) that are of clinical and scientific interest, the DSMB left it to the discretion of the Steering Committee to continue enrollment to meet sufficient power for these outcomes. On March 1, 2013, the Steering Committee met to discuss these issues and voted to continue enrollment until the planned sample size for the Quality of Life substudy was met (300 patients).
- Being tested
- Transradial PCI, Transfemoral PCI
- Keywords
- Female, urgent or elective percutaneous coronary intervention, PCI, diagnostic angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transradial PCIProcedure or surgery
Transradial PCI
Transfemoral PCIProcedure or surgery
Transfemoral PCI
| Study group | Role | What they receive |
|---|---|---|
| Transradial PCI | Other | Not described Receives: Procedure: Transradial PCI |
| Transfemoral PCI | Other | Not described Receives: Procedure: Transfemoral PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: Composite of BARC Types 2, 3, and 5 bleeding or vascular complications.
Measured: From first arterial access post-randomization to 72 hours or hospital discharge, whichever occurs first.
Primary Feasibility Endpoint: Procedural failure, defined as inability to complete the procedure from the assigned vascular access site.
Measured: From first arterial access post-randomization to 72 hours or hospital discharge, whichever occurs first.
Secondary outcomes (3)
Procedure Duration, total radiation dose and total contrast volume
To determine the effect of transradial PCI on procedure time, total radiation dose, and total contrast volume.
Measured: 72 hours post randomization or hospital discharge (whichever occurs first)
Resource Use, patient preferences and quality of life
To determine the effect of transradial PCI on resource use, patient preferences, and quality of life.
Measured: Baseline, 72 hours post randomization or hospital discharge (whichever occurs first), 30 day
30-day death, vascular complications, or repeat revascularization
To determine the effect of transradial PCI on 30-day death, vascular complications, or repeat revascularization.
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Study stopped for Statistical Futility. Low rate of bleeding events made it unlikely there would be statistical power to show a difference in the 2 arms.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 1,787 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Cardiology, Abbott Medical Devices, Lilly USA, Medtronic, Terumo Medical Corporation, The Medicines Company, Acist Medical Systems, Guerbet, Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Sunil V Rao, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406236
- Sponsor's protocol ID
- Pro00030109
- Acronym
- SAFE-PCI
- Status last verified
- Jan 2015
- First submitted
- 20 Jun 2011
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rymer JA, Kaltenbach LA, Kochar A, Hess CN, Gilchrist IC, Messenger JC, Harrington RA, Jolly SS, Jacobs AK, Abbott JD, Wojdyla DM, Krucoff MW, Rao SV. Comparison of Rates of Bleeding and Vascular Complications Before, During, and After Trial Enrollment in the SAFE-PCI Trial for Women. Circ Cardiovasc Interv. 2019 May;12(5):e007086. doi: 10.1161/CIRCINTERVENTIONS.118.007086.
PubMed 31014090Rao SV, Hess CN, Barham B, Aberle LH, Anstrom KJ, Patel TB, Jorgensen JP, Mazzaferri EL Jr, Jolly SS, Jacobs A, Newby LK, Gibson CM, Kong DF, Mehran R, Waksman R, Gilchrist IC, McCourt BJ, Messenger JC, Peterson ED, Harrington RA, Krucoff MW. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial. JACC Cardiovasc Interv. 2014 Aug;7(8):857-67. doi: 10.1016/j.jcin.2014.04.007.
PubMed 25147030Hess CN, Rao SV, Kong DF, Aberle LH, Anstrom KJ, Gibson CM, Gilchrist IC, Jacobs AK, Jolly SS, Mehran R, Messenger JC, Newby LK, Waksman R, Krucoff MW. Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women). Am Heart J. 2013 Sep;166(3):421-8. doi: 10.1016/j.ahj.2013.06.013. Epub 2013 Jul 23.
PubMed 24016489
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Access Site for Enhancement of PCI for Women (SAFE-PCI for Women)
- ClinicalTrials.gov ID
- NCT01406236
- Acronym / sponsor ID
- SAFE-PCI / Pro00030109
- Keywords
- Female, urgent or elective percutaneous coronary intervention, PCI, diagnostic angiography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped for Statistical Futility. Low rate of bleeding events made it unlikely there would be statistical power to show a difference in the 2 arms.
- Enrolment
- 1,787 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- American College of Cardiology, Abbott Medical Devices, Lilly USA, Medtronic, Terumo Medical Corporation, The Medicines Company, Acist Medical Systems, Guerbet, Food and Drug Administration (FDA)
- Study start
- Aug 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 Aug 2011 (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 hypothesis of the SAFE-PCI for women trial is that, compared with transfemoral PCI, transradial PCI will result in a significant reduction in bleeding and vascular complications. The primary objective is to compare the efficacy and feasibility of the transradial approach to percutaneous coronary intervention (PCI) in women compared with the transfemoral approach.
This study is a multicenter, randomized, open-label active controlled study. Three thousand women undergoing urgent or elective PCI from at least 50 centers will be randomized to either transradial or transfemoral PCI. Patients who are enrolled at sites performing ad hoc PCI will be randomized before diagnostic angiography. A total of approximately 3000 women will be randomized to obtain a cohort of approximately 1800 patients undergoing PCI.
The Data Safety Monitoring Board has alerted us that the bleeding event rate overall in our trial is very low, making it unlikely that there will be statistical power to show a difference between the randomized arms in the SAFE PCI for Women study using the BARC bleeding definition per protocol. Based on this statistical futility, the DSMB has recommended stopping enrollment. They also noted, however, that as this is not based on any safety issues, and since there are a variety of key secondary endpoints (contrast and radiation exposure, quality of life) that are of clinical and scientific interest, the DSMB left it to the discretion of the Steering Committee to continue enrollment to meet sufficient power for these outcomes. On March 1, 2013, the Steering Committee met to discuss these issues and voted to continue enrollment until the planned sample size for the Quality of Life substudy was met (300 patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transradial PCI | Other | Procedure: Transradial PCI |
| Transfemoral PCI | Other | Procedure: Transfemoral PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have the capacity to understand and sign an informed consent form
- Age ≥ 18 years
- Female patient undergoing urgent or elective PCI or undergoing diagnostic angiography to evaluate ischemic symptoms with the possibility of PCI
Key exclusion criteria (12 listed)
- Peripheral arterial disease that prohibits vascular access
- Bilateral abnormal Barbeau tests
- Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (note that the opposite arm may be used for radial access in case a dialysis graft is present in one arm provided that the opposite arm has a normal Barbeau test)
- International normalized ratio (INR) ≥ 1.5 in a patient treated with oral vitamin K antagonists (i.e., warfarin).
- Receipt of oral Factor Xa or IIa inhibitors ≤ 24 hours prior to the procedure
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 |
|---|---|---|
| Transradial PCITransradial PCI | Procedure or surgery | Transradial PCI |
| Transfemoral PCITransfemoral PCI | Procedure or surgery | Transfemoral PCI |
Primary outcome
Primary Efficacy Endpoint: Composite of BARC Types 2, 3, and 5 bleeding or vascular complications.
Time frame: From first arterial access post-randomization to 72 hours or hospital discharge, whichever occurs first.
Primary Feasibility Endpoint: Procedural failure, defined as inability to complete the procedure from the assigned vascular access site.
Time frame: From first arterial access post-randomization to 72 hours or hospital discharge, whichever occurs first.
3 secondary outcomes
Procedure Duration, total radiation dose and total contrast volume
Time frame: 72 hours post randomization or hospital discharge (whichever occurs first)
Resource Use, patient preferences and quality of life
Time frame: Baseline, 72 hours post randomization or hospital discharge (whichever occurs first), 30 day
30-day death, vascular complications, or repeat revascularization
Time frame: 30 day
Results and safety
The study was stopped early (reason given: Study stopped for Statistical Futility. Low rate of bleeding events made it unlikely there would be statistical power to show a difference in the 2 arms.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
- Derived from this study: PubMed 31014090Rymer JA, Kaltenbach LA, Kochar A, Hess CN, Gilchrist IC, Messenger JC, Harrington RA, Jolly SS, Jacobs AK, Abbott JD, Wojdyla DM, Krucoff MW, Rao SV. Comparison of Rates of Bleeding and Vascular Complications Before, During, and After Trial Enrollment in the SAFE-PCI Trial for Women. Circ Cardiovasc Interv. 2019 May;12(5):e007086. doi: 10.1161/CIRCINTERVENTIONS.118.007086.
- Derived from this study: PubMed 25147030Rao SV, Hess CN, Barham B, Aberle LH, Anstrom KJ, Patel TB, Jorgensen JP, Mazzaferri EL Jr, Jolly SS, Jacobs A, Newby LK, Gibson CM, Kong DF, Mehran R, Waksman R, Gilchrist IC, McCourt BJ, Messenger JC, Peterson ED, Harrington RA, Krucoff MW. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial. JACC Cardiovasc Interv. 2014 Aug;7(8):857-67. doi: 10.1016/j.jcin.2014.04.007.
- Derived from this study: PubMed 24016489Hess CN, Rao SV, Kong DF, Aberle LH, Anstrom KJ, Gibson CM, Gilchrist IC, Jacobs AK, Jolly SS, Mehran R, Messenger JC, Newby LK, Waksman R, Krucoff MW. Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women). Am Heart J. 2013 Sep;166(3):421-8. doi: 10.1016/j.ahj.2013.06.013. Epub 2013 Jul 23.
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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.
Sunil V Rao, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Transradial PCI and Transfemoral PCI in people with Percutaneous Coronary Intervention and Ischemic Symptoms, run by Duke University.
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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 21 Jan 2015. 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 stopped early (reason given: Study stopped for Statistical Futility. Low rate of bleeding events made it unlikely there would be statistical power to show a difference in the 2 arms.). Results are not available in the source record.
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?
Primary Efficacy Endpoint: Composite of BARC Types 2, 3, and 5 bleeding or vascular complications. (time frame: From first arterial access post-randomization to 72 hours or hospital discharge, whichever occurs first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01406236, which also lists 3 linked publications.
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 21 Jan 2015.