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PCINCT06585917

Comparison of 6F and 7F Sheaths for Coronary Intervention Via Distal Radial Artery Access

A study testing 7F Thin-Walled Sheath and 6F Thin-Walled Sheath in people with PCI and Coronary Arterial Disease (CAD), run by China National Center for Cardiovascular Diseases at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multicenter, randomized controlled, prospective, non-inferiority, open-label study aiming to evaluate whether the efficacy and safety of using a 7F thin-walled sheath via distal radial artery (dTRA) access for coronary intervention (PCI) are non-inferior to the use of a 6F thin-walled sheath. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
PCI, Coronary Arterial Disease (CAD)
What is being tested?
7F Thin-Walled Sheath and 6F Thin-Walled Sheath
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
574 participants
Where
1 siteChina
Study dates
10 Sep 2024to 30 Jan 2026
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

  • Age ≥18 years and ≤80 years;
  • Height ≤180 cm;
  • Distal radial artery diameter ≥1.7 mm;
  • Completed distal radial artery angiography and requires coronary intervention;
  • Tolerates dual antiplatelet therapy and intraoperative anticoagulant therapy, with no history of related drug allergies;
  • Patient consents to participate in the study.

Who cannot join

  • Acute myocardial infarction requiring emergency PCI;
  • Ultrasound-confirmed occlusion of the radial artery on the procedure side;
  • Radial artery and distal radial artery anomalies (e.g., small caliber, tortuous, looped vessels) that make the dTRA approach unsuitable;
  • Previous bilateral radial artery intervention or surgery;
  • No coronary intervention performed after coronary angiography;
  • Inability to undergo coronary angiography and intervention due to subjective or objective reasons;
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  • Coronary lesions requiring the use of a 7F guiding catheter;
  • Coronary arteries not suitable for 7F guiding catheter;
  • Severe liver or renal insufficiency, unresolved bleeding disorders, or other serious conditions with an expected survival of less than 1 year;
  • Currently breastfeeding or known pregnancy.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai Hospital, CAMS & PUMC

    Beijing, Beijing Municipality, 100037

Other trials in China

About this study

Official title: A Multicenter Study Comparing the Efficacy and Safety of 6F and 7F Thin-Walled Sheaths Via Distal Radial Artery Access for Coronary Intervention

This is a multicenter, randomized controlled, prospective, non-inferiority, open-label study aiming to evaluate whether the efficacy and safety of using a 7F thin-walled sheath via distal radial artery (dTRA) access for coronary intervention (PCI) are non-inferior to the use of a 6F thin-walled sheath. The study population includes adult patients who are candidates for coronary intervention. The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure.

Read the detailed description

This study is a multicenter, randomized controlled, prospective, non-inferiority, open-label clinical trial designed to compare the efficacy and safety of using 7F thin-walled sheaths versus 6F thin-walled sheaths for coronary intervention (PCI) via distal radial artery access (dTRA). The study will enroll adult patients with coronary artery disease who are scheduled to undergo PCI.

Participants will be randomized into two groups: the experimental group, which will receive PCI using a 7F sheath, and the control group, which will receive PCI using a 6F sheath. The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure, assessed by ultrasound. Secondary endpoints include the incidence of major adverse cardiovascular and cerebrovascular events during follow-up, cannulation success rate, PCI success rate, and the rate of radial artery occlusion at 30 days post-procedure, among others.

The study aims to determine whether the 7F sheath is non-inferior to the 6F sheath in terms of safety and efficacy for PCI through dTRA. The study will be conducted at multiple centers in China, with a planned enrollment of 574 participants, and it will span from Sep 2024 to January 2026. All procedures will adhere to the highest standards of clinical practice, and patient data will be managed with strict confidentiality.

Being tested
7F Thin-Walled Sheath, 6F Thin-Walled Sheath
Keywords
Distal Radial Artery Access, Coronary Intervention, 7F Sheath, 6F Sheath, Radial Artery Occlusion, Non-Inferiority Trial
Medical subject headings
Arterial Occlusive Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 7F Thin-Walled SheathDevice

    The 7F Thin-Walled Sheath is used during coronary intervention procedures via distal radial artery access. This device has a smaller outer diameter compared to traditional 7F sheaths, designed to reduce the risk of vascular complications while allowing for the performance of complex coronary interventions.

  • 6F Thin-Walled SheathDevice

    The 6F Thin-Walled Sheath is the standard device used in coronary intervention procedures via distal radial artery access. It is employed as a control in this study to compare its efficacy and safety against the 7F Thin-Walled Sheath.

Study groups in NCT06585917
Study groupRoleWhat they receive
7F Sheath Intervention GroupExperimentalParticipants in this arm will undergo coronary intervention using a 7F thin-walled sheath via distal radial artery access. This group will be used to assess the efficacy and safety of the 7F sheath compared to the 6F sheath.
Receives: Device: 7F Thin-Walled Sheath
6F Sheath Control GroupActive comparatorParticipants in this arm will undergo coronary intervention using a 6F thin-walled sheath via distal radial artery access. This group will serve as the control to compare the outcomes against those of the 7F sheath group.
Receives: Device: 6F Thin-Walled Sheath

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radial Artery Occlusion Rate 24 Hours Post-Procedure

    The primary outcome is the rate of radial artery and distal radial artery occlusion 24 hours after the procedure. Occlusion will be determined by the absence of blood flow spectrum in the radial artery as assessed by ultrasound.

    Measured: 24 hours post-procedure

Secondary outcomes (11)

  1. Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

    The incidence of major adverse cardiovascular and cerebrovascular events during the follow-up period, including all-cause mortality, cardiovascular mortality, new-onset myocardial infarction, and new-onset stroke.

    Measured: Up to 30 days post-procedure

  2. Cannulation Success Rate

    The success rate of sheath insertion and placement in the radial artery during the coronary intervention procedure.

    Measured: During the procedure

  3. PCI Success Rate

    The success rate of the percutaneous coronary intervention (PCI) procedure, defined by the successful completion of the intended intervention with appropriate device placement and without the need for conversion to an alternative access site.

    Measured: During the procedure

  4. Radial Artery Occlusion Rate 30 Days Post-Procedure

    The rate of radial artery and distal radial artery occlusion 30 days after the procedure, assessed by ultrasound.

    Measured: 30 days post-procedure

  5. Major Bleeding Events

    The incidence of major bleeding events, defined according to the Bleeding Academic Research Consortium (BARC) criteria (Type 3 or Type 5 bleeding).

    Measured: Up to 30 days post-procedure

  6. Local Neurological Complications

    The incidence of local neurological complications, including numbness, tingling, or motor deficits in the arm used for radial artery access.

    Measured: Up to 30 days post-procedure

  7. Incidence and Severity of Forearm Hematoma

    Forearm hematoma will be graded using the EASY (Early Discharge After Transradial Stenting of Coronary Arteries Study) hematoma scale. The scale ranges from Grade I to Grade V:

    Grade I: Hematoma \<5 cm in diameter (non-significant) Grade II: Hematoma 5-10 cm in diameter (mild) Grade III: Hematoma \>10 cm but distal to the elbow (moderate) Grade IV: Hematoma extending above the elbow (severe) Grade V: Hematoma associated with ischemic threat to the hand (compartment syndrome) Higher grades indicate worse outcomes.

    Measured: Up to 30 days post-procedure

  8. Pain Scores

    Patient-reported pain scores assessed using the Visual Analog Scale (VAS). The scale ranges from 0 (no pain) to 10 (worst pain), with higher scores indicating worse outcomes.

    Measured: Up to 30 days post-procedure

  9. Daily Living Ability Scores

    Daily living abilities assessed using the Barthel Index, which ranges from 0 (complete dependence) to 100 (complete independence), with higher scores indicating better outcomes.

    Measured: Up to 30 days post-procedure

  10. Length of Hospital Stay

    The total length of hospital stay, measured in days, starting from the date of admission for the coronary intervention procedure until the date of discharge, with a maximum assessment period of up to 30 days post-procedure.

    Measured: From the time of admission for the procedure until the date of discharge, assessed up to 30 days post-procedure

  11. Unplanned Additional Interventions During Hospitalization

    The incidence of unplanned additional interventions required during the initial hospitalization, including but not limited to additional PCI, vascular repair, or treatment of complications. The events will be assessed from the time of the procedure until the patient is discharged, with a maximum assessment period of up to 30 days post-procedure.

    Measured: From the time of procedure until discharge, assessed up to 30 days post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start10 Sep 2024
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Jan 2026 (estimated)

Resources

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
Model description
This study uses a Parallel Assignment model, where participants are randomly assigned to one of two groups: the 7F sheath intervention group or the 6F sheath control group. Each group will receive a different size sheath for coronary intervention via distal radial artery access. The study is designed to compare the outcomes between these two groups, with no crossover between groups during the trial. This model allows for a direct comparison of the efficacy and safety between the two sheath sizes under similar clinical conditions.
Masking
None (open label)
Enrolment
574 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06585917
Sponsor's protocol ID
2024-2377
Status last verified
Sep 2024
First submitted
2 Sep 2024
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The decision not to share individual participant data (IPD) is based on concerns related to patient confidentiality and data privacy. While all data collected in this study will be securely stored and managed, the nature of the data involves sensitive health information that could potentially identify participants. Furthermore, the current study does not have the necessary infrastructure or resources in place to manage the secure and controlled distribution of IPD to external researchers. Therefore, to protect participant privacy and adhere to ethical standards, we have decided not to share IPD for this trial.

Publications

  • Liu M, Du Y, Cui C, Li C, Yu W, Wang H, Song Y, Gao Z, Song L, Zhai J, Yang Y, Yang W, Wu Y, Liu D, Guo J, Heisha N, Liu H, Zhao Y, Zhang F, Tang Y, Zhao Y, Yu M, Zhang B, Yang J, Li R, Li H, Xiong X, Guo X, Li H, Song Y, Duan F, Gao L. Distal Radial Artery Access With 6F and 7F Thin-Walled Sheaths for Coronary Intervention: A Multicentre, Randomized, DRAWS Trial Protocol. Can J Cardiol. 2025 Dec;41(12):2420-2428. doi: 10.1016/j.cjca.2025.09.002. Epub 2025 Sep 13.

    PubMed 40953816

Questions about this trial

What is this clinical trial studying?

A study testing 7F Thin-Walled Sheath and 6F Thin-Walled Sheath in people with PCI and Coronary Arterial Disease (CAD), run by China National Center for Cardiovascular Diseases at 1 site in China.

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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

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?

Radial Artery Occlusion Rate 24 Hours Post-Procedure (time frame: 24 hours post-procedure). 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 NCT06585917, 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 Feb 2025.

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