Coronary Artery DiseaseSEVEN-BOXNCT05006027
Feasibility of PCI Using a 7-Fr Thin-Walled Sheath Via the DRA
An observational study of Coronary Artery Disease and Distal Radial Artery, run by Yonsei University at 2 sites in South Korea.
Trial summary
To evaluate the safety and effectiveness of percutaneous coronary intervention using a 7-French(Fr) thin-walled sheath via the distal radial approach Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Distal Radial Artery, Complex Intervention
- What is being tested?
- Percutaneous coronary intervention via the distal radial approach
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 16 Aug 2021to 15 Oct 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 19 years and older
- All sexes
- Adult, Older adult
Study population: patients with coronary artery disease who planned to perform PCI using a 7-Fr thin-walled sheath will be recruited
Who may be able to join
- Patients, ≥ 19 years of age, who were diagnosed with ischemic heart disease requiring percutaneous coronary intervention (PCI)
- Patients who are palpable distal radial artery
- The decision to participate voluntarily in this study and the written consent of the patient
- Patients who planned to perform PCI using a 7-Fr thin-walled sheath
Who cannot join
- Patients who are not palpable distal radial artery
- Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study
- Pregnancy
- Patients who are not appropriate for this study
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Yongin Severance Hospital
Yongin, Gyeonggi-do, 16995
Yongin Severance Hospital
Yŏngin
About this study
Official title: Feasibility of Percutaneous Coronary Intervention Using a 7-Fr Thin Walled Sheath Via the Distal Radial Approach: a Prospective Observational Study (SEVEN-BOX)
To evaluate the safety and effectiveness of percutaneous coronary intervention using a 7-French(Fr) thin-walled sheath via the distal radial approach
Read the detailed description
Recently, coronary angiography (CAG) and percutaneous coronary intervention (PCI) via the distal radial artery access (DRA) have shown several advantages owing to fewer complications, such as radial artery occlusion, pseudoaneurysms, and arteriovenous(AV) fistulas, and short hemostasis duration than the proximal radial access (PRA). However, despite the potential advantages of the DRA, there are still many cardiologists who prefer the femoral approach for complex PCI including left main disease, bifurcation lesions, heavily calcified lesions, which need a strong backup and using several devices. The radial artery and the distal radial artery have a smaller diameter than the femoral artery, and interventional cardiologists are usually performed using the 6-Fr sheath. The previously developed 7-Fr sheath has a higher risk of vascular occlusion when use in a radial artery due to larger diameter compared to radial artery in 30% to 60% of patients. However, with the recent development of various technologies, the outer diameter of the sheath is gradually becoming thinner and recently a 7-Fr thin-walled sheath which does not differ significantly from the outer diameter of the 6-Fr sheath used in the previously PRA demonstrated that feasibility and safety for radial artery intervention. Despite the feasibility and potential benefits of the DRA and 7-Fr thin-walled sheath for radial artery, there is a lack of data regarding the safety and efficacy of a 7-Fr thin-walled sheath during the DRA.
- Being tested
- Percutaneous coronary intervention via the distal radial approach
- Keywords
- distal radial artery, coronary artery disease, percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention via the distal radial approachProcedure or surgery
Percutaneous coronary intervention using a 7-Fr thin walled sheath (Prelude IDeal, MERIT MEDICAL, South Jordan, UT, USA) via the distal radial approach
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous coronary intervention using a 7-Fr thin-walled sheath via the distal radial approach | patients with coronary artery disease who planned to perform PCI using 7-Fr thin-walled sheath via the distal radial approach Receives: Procedure: Percutaneous coronary intervention via the distal radial approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access site complication during hospitalization and within 1-month follow-up
bleeding(defined by BARC criteria), hematoma (using modified EASY[Early Discharge After Transradial Stenting of Coronary Arteries Study] classification: A) Grade Ia hematoma was subclassified into 4 grades from the puncture site [Grade 1, <2cm; Grade2, 2-5cm; Grade3,>5cm; and grade 4, hand swelling], B) Grade Ib, wrist < 5cm, C) Grade II, wrist < 10cm, D) Grade III, forearm, E) Grade IV, upper arm), numbness, AV fistula, Pseudoaneurysm, and conventional and distal radial artery occlusion (assessed by manual palpation or ultrasonography[prefer])
Measured: Through procedure completion, up to 1month
Success rate of PCI
Success rate of PCI using 7-Fr sheath via the distal radial approach (%)
Measured: Through procedure completion, up to 1month
Secondary outcomes (3)
Hemostasis duration
Hemostasis duration using 7-Fr thin-walled sheath via the distal radial approach (minute)
Measured: Through procedure completion, up to 24 hours
Patency of proximal radial artery after hemostasis
Patency of proximal radial artery using 7-Fr thin-walled sheath via the distal radial approach by ultrasonography after hemostasis (%)
Measured: Through procedure completion, up to 24 hours
Patency of distal radial artery after 1 month
Patency of distal radial artery using 7-Fr thin-walled sheath via the snuffbox approach by ultrasonography after 1-month (%)
Measured: Time Frame: up to 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start16 Aug 2021
- Primary completion17 Jul 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Merit Medical Systems, Inc.
- Responsible party
- Principal investigator, Yongcheol Kim, Yonsei University
- Investigators
- Yongcheol Kim, MD, Principal investigator, Yongin Severance Hopistal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006027
- Sponsor's protocol ID
- 9-2021-0031
- Acronym
- SEVEN-BOX
- Status last verified
- Nov 2025
- First submitted
- 8 Aug 2021
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No planned
Publications
Roh JW, Lee OH, Heo SJ, Kim Y, Im E, Cho DK. Feasibility of percutaneous coronary intervention using a 7-French thin-walled sheath via the distal radial access. Sci Rep. 2025 May 15;15(1):16961. doi: 10.1038/s41598-025-01149-1.
PubMed 40374669
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Percutaneous Coronary Intervention Using a 7-Fr Thin Walled Sheath Via the Distal Radial Approach: a Prospective Observational Study (SEVEN-BOX)
- ClinicalTrials.gov ID
- NCT05006027
- Acronym / sponsor ID
- SEVEN-BOX / 9-2021-0031
- Keywords
- distal radial artery, coronary artery disease, percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Severance Hospital, Merit Medical Systems, Inc.
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 16 Aug 2021 (actual)
- 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.
To evaluate the safety and effectiveness of percutaneous coronary intervention using a 7-French(Fr) thin-walled sheath via the distal radial approach
Detailed description
Recently, coronary angiography (CAG) and percutaneous coronary intervention (PCI) via the distal radial artery access (DRA) have shown several advantages owing to fewer complications, such as radial artery occlusion, pseudoaneurysms, and arteriovenous(AV) fistulas, and short hemostasis duration than the proximal radial access (PRA). However, despite the potential advantages of the DRA, there are still many cardiologists who prefer the femoral approach for complex PCI including left main disease, bifurcation lesions, heavily calcified lesions, which need a strong backup and using several devices. The radial artery and the distal radial artery have a smaller diameter than the femoral artery, and interventional cardiologists are usually performed using the 6-Fr sheath. The previously developed 7-Fr sheath has a higher risk of vascular occlusion when use in a radial artery due to larger diameter compared to radial artery in 30% to 60% of patients. However, with the recent development of various technologies, the outer diameter of the sheath is gradually becoming thinner and recently a 7-Fr thin-walled sheath which does not differ significantly from the outer diameter of the 6-Fr sheath used in the previously PRA demonstrated that feasibility and safety for radial artery intervention. Despite the feasibility and potential benefits of the DRA and 7-Fr thin-walled sheath for radial artery, there is a lack of data regarding the safety and efficacy of a 7-Fr thin-walled sheath during the DRA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous coronary intervention using a 7-Fr thin-walled sheath via the distal radial approach | – | Procedure: Percutaneous coronary intervention via the distal radial approachpatients with coronary artery disease who planned to perform PCI using 7-Fr thin-walled sheath via the distal radial approach |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with coronary artery disease who planned to perform PCI using a 7-Fr thin-walled sheath will be recruited
Key inclusion criteria (4 listed)
- Patients, ≥ 19 years of age, who were diagnosed with ischemic heart disease requiring percutaneous coronary intervention (PCI)
- Patients who are palpable distal radial artery
- The decision to participate voluntarily in this study and the written consent of the patient
- Patients who planned to perform PCI using a 7-Fr thin-walled sheath
Key exclusion criteria (4 listed)
- Patients who are not palpable distal radial artery
- Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study
- Pregnancy
- Patients who are not appropriate for this study
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 |
|---|---|---|
| Percutaneous coronary intervention via the distal radial approachPercutaneous coronary intervention using a 7-Fr thin walled sheath (Prelude IDeal, MERIT MEDICAL, South Jordan, UT, USA) via the distal radial approach | Procedure or surgery | Percutaneous coronary intervention using a 7-Fr thin-walled sheath via the distal radial approach |
Primary outcome
Access site complication during hospitalization and within 1-month follow-up
Time frame: Through procedure completion, up to 1month
bleeding(defined by BARC criteria), hematoma (using modified EASY[Early Discharge After Transradial Stenting of Coronary Arteries Study] classification: A) Grade Ia hematoma was subclassified into 4 grades from the puncture site [Grade 1, <2cm; Grade2, 2-5cm; Grade3,>5cm; and grade 4, hand swelling], B) Grade Ib, wrist < 5cm, C) Grade II, wrist < 10cm, D) Grade III, forearm, E) Grade IV, upper arm), numbness, AV fistula, Pseudoaneurysm, and conventional and distal radial artery occlusion (assessed by manual palpation or ultrasonography[prefer])
Success rate of PCI
Time frame: Through procedure completion, up to 1month
Success rate of PCI using 7-Fr sheath via the distal radial approach (%)
3 secondary outcomes
Hemostasis duration
Time frame: Through procedure completion, up to 24 hours
Patency of proximal radial artery after hemostasis
Time frame: Through procedure completion, up to 24 hours
Patency of distal radial artery after 1 month
Time frame: Time Frame: up to 1month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Derived from this study: PubMed 40374669Roh JW, Lee OH, Heo SJ, Kim Y, Im E, Cho DK. Feasibility of percutaneous coronary intervention using a 7-French thin-walled sheath via the distal radial access. Sci Rep. 2025 May 15;15(1):16961. doi: 10.1038/s41598-025-01149-1.
- Individual participant dataSharing planned: No. No planned
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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.
Yongcheol Kim, MD principal investigator
Yongin Severance Hopistal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Distal Radial Artery, run by Yonsei University at 2 sites in South Korea.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Access site complication during hospitalization and within 1-month follow-up (time frame: Through procedure completion, up to 1month). 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 NCT05006027, which also lists 1 linked publication.
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 25 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.