Coronary Artery DiseaseDISTAL-SVNCT07410364
Safety and Efficacy of CAG and PCI Via Distal Transradial Access in Patients With Small Vessels
A study testing Performing coronary angiography and percutaneous coronary intervention via the distal transradial access in patients with small vessels (DRA < 2.0 mm) using a 6-Fr Glidesheath Slender sheath. and Performing coronary interventional procedures via the distal radial artery in patients with small vessels ( DRA diameter < 2.0 mm ) using a 6-Fr Conventional sheath. in people with Coronary Artery Disease, run by Cai gaojun, MD at 2 sites in China.
Trial summary
Randomized controlled trial of adaptive design for the safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial access using a 6-French Glidesheath Slender in patients with small vessels. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Performing coronary angiography and percutaneous coronary intervention via the distal transradial access in patients with small vessels (DRA < 2.0 mm) using a 6-Fr Glidesheath Slender sheath. and Performing coronary interventional procedures via the distal radial artery in patients with small vessels ( DRA diameter < 2.0 mm ) using a 6-Fr Conventional sheath.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 594 participants
- Where
- 2 sitesChina
- Study dates
- 24 Feb 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years
- Palpable pulses in both the distal radial artery and conventional radial artery
- All patients signed informed consent forms prior to procedure
Who cannot join
- Ultrasound assessment of the distal radial artery diameter ≥2.0mm or <1.0mm
- Height ≥185.0cm
- Patients with acute ST-segment elevation myocardial infarction, cardiogenic shock, or hemodynamic instability
- Contraindications for puncture of the distal radial artery
- Patients with Raynaud's syndrome
- Patients with coagulation disorders or hematologic diseases
- Patients currently enrolled in other clinical studies
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Changzhou Wujin People's Hospital
Changzhou, Jiangsu, 213017
Gaojun Cai, MD, +86-0519-85579193, cgj982@126.com
- Recruiting
Wujin Hospital Affiliated with Jiangsu University.
Changzhou, Jiangsu, 213017
About this study
Official title: Safety and Efficacy of 6-French Glidesheath Slender in Coronary Angiography and Percutaneous Coronary Intervention Via Distal Transradial Access in Patients With Small Vessels: A Single-Center, Adaptive, Randomized Controlled Study
Randomized controlled trial of adaptive design for the safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial access using a 6-French Glidesheath Slender in patients with small vessels.
Read the detailed description
The safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial access (dTRA) have been confirmed by a large number of studies, but there are still few studies on its safety and efficacy in patients with small vessels (distal radial artery diameter < 2.0mm). The 6-French Glidesheath Slender, with its smaller outer diameter, should be more suitable for patients with small vessels. To this end, we plan to conduct a single-center, adaptive, randomized controlled trial enrolling 594 patients aged 18-85 years old with distal radial artery diameters <2.0 mm and ≥1.0 mm who are scheduled to undergo coronary angiography and percutaneous coronary intervention via the distal radial artery approach in our center. The study employed a stratification-block randomized design. Stratification was performed based on patient gender, with a block size of 4 within each stratum. Eligible patients were randomly assigned in a 1:1 ratio to either the 6-French Glidesheath Slender group or the 6-French conventional sheath group.
The primary endpoint of the study was distal radial artery occlusion assessed by vascular ultrasound 24 hours postoperatively. Secondary endpoints included puncture success rate, procedure success rate, number of punctures, puncture time, total procedural time, visual analogue scale pain scores during sheath placement, bleeding, hematoma, arteriovenous fistula, finger numbness, and conventional radial artery occlusion at 24 hours postoperatively.
An interim analysis will be conducted when 50% of the total sample size (297 patients) is enrolled, with subsequent sample size adjustments based on preliminary study results.
The results of this study will provide evidence for the safety and efficacy of 6-French Glidesheath Slender for coronary angiography and percutaneous coronary intervention in patients with small vessels via distal transradial access, and provide information for the selection of the best sheath equipment for patients with small vessels.
- Conditions
- Coronary Artery Disease
- Being tested
- Performing coronary angiography and percutaneous coronary intervention via the distal transradial access in patients with small vessels (DRA < 2.0 mm) using a 6-Fr Glidesheath Slender sheath., Performing coronary interventional procedures via the distal radial artery in patients with small vessels ( DRA diameter < 2.0 mm ) using a 6-Fr Conventional sheath.
- Keywords
- Distal radial artery, Small vessel, Ultrasound, Distal radial artery occlusion, Radial artery occlusion, Visual analog scale, Safety, Efficacy
- Medical subject headings
- Coronary Artery Disease, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing coronary angiography and percutaneous coronary intervention via the distal transradial access in patients with small vessels (DRA < 2.0 mm) using a 6-Fr Glidesheath Slender sheath.Device
Also called 6-French Glidesheath Slender
Coronary angiography and percutaneous coronary intervention was performed in participants with small vessels (DRA < 2.0 mm) via the distal transradial access using a 6-French Glidesheath Slender sheath.
Performing coronary interventional procedures via the distal radial artery in patients with small vessels ( DRA diameter < 2.0 mm ) using a 6-Fr Conventional sheath.Device
Also called 6-Fr Conventional sheath
Coronary angiography and percutaneous coronary intervention was performed in participants with small vessels (DRA < 2.0 mm) via the distal transradial access using a 6-French Conventional sheath.
| Study group | Role | What they receive |
|---|---|---|
| 6-French Glidesheath Slender group | Experimental | Performing coronary angiography and percutaneous coronary intervention via the distal transradial access using a 6-French Glidesheath Slender sheath. Receives: Device: Performing coronary angiography and percutaneous coronary intervention via the distal transradial access in patients with small vessels (DRA < 2.0 mm) using a 6-Fr Glidesheath Slender sheath. |
| 6-F Conventional sheath group | Sham comparator | Performing coronary angiography and percutaneous coronary intervention via the distal transradial access using a 6-F Conventional sheath. Receives: Device: Performing coronary interventional procedures via the distal radial artery in patients with small vessels ( DRA diameter < 2.0 mm ) using a 6-Fr Conventional sheath. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal radial artery occlusion(dRAO)
The dRAO is defined as the absence of blood flow in the distal radial artery assessed by the doppler ultrasound.
Measured: 24 hours postoperatively.
Secondary outcomes (11)
Puncture success
Puncture success is defined as complete insertion of the artery sheath.
Measured: Periprocedural
Procedure success
Procedure success is defined as the whole procedure was completed from the same access.
Measured: Periprocedural
Number of punctures
The number of punctures is defined as the number of attempts made before a successful puncture.
Measured: Periprocedural
Puncture time(second)
Puncture time is defined as the time from the end of local anaesthesia to the sheath completely implanted into the vessel.
Measured: Periprocedural
Procedural time(minute)
Procedural time is defined as the time from the initiation of the puncture to the completion of the procedure.
Measured: Periprocedural
Visual Analogue Scale (VAS) pain scores(0-10) during sheath placement
With a 10-cm straight line divided into 10 equal parts to rate pain with 0 indicating no pain and 10 for extreme pain.
Measured: Periprocedural
Bleeding
Bleeding events are defined according to the BARC criteria.
Measured: 24 hours postoperatively
Haematoma
Haematoma was assessed according to the mEASY( A modified version of the Early Discharge After Transradial Stenting of Coronary Arteries Study) classification.
Measured: 24 hours postoperatively
Arteriovenous fistula
Number of participants with the arteriovenous fistula is assessed by the doppler ultrasound 24 hours postoperatively.
Measured: 24 hours postoperatively.
Finger numbness
Number of participants with the finger numbness 24 hours postoperatively.
Measured: 24 hours postoperatively
Conventional radial artery occlusion (cRAO)
The cRAO is defined as the absence of blood flow in the conventional radial artery assessed by the doppler ultrasound.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start24 Feb 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cai gaojun, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cai gaojun, MD, Wujin People's Hospital
- Investigators
- haiyan HY zhang, BS, Principal investigator, Wujin Hospital Affiliated with Jiangsu University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410364
- Sponsor's protocol ID
- 2025-SR-229
- Acronym
- DISTAL-SV
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li F, Zhou T, Fan X, Chen T, Shi G, Li L, Cai G. Safety and Efficacy of Distal Transradial Access in Patients With Small Diameter Distal Radial Artery: A Post Hoc Analysis of 2 Randomized Trials. Can J Cardiol. 2026 Jun;42(6):1221-1229. doi: 10.1016/j.cjca.2025.12.048. Epub 2025 Dec 30.
PubMed 41478549Kim Y, Ahn Y, Kim I, Lee DH, Kim MC, Sim DS, Hong YJ, Kim JH, Jeong MH. Feasibility of Coronary Angiography and Percutaneous Coronary Intervention via Left Snuffbox Approach. Korean Circ J. 2018 Dec;48(12):1120-1130. doi: 10.4070/kcj.2018.0181. Epub 2018 Aug 6.
PubMed 30088362Lin Y, Sun X, Chen R, Liu H, Pang X, Chen J, Dong S. Feasibility and Safety of the Distal Transradial Artery for Coronary Diagnostic or Interventional Catheterization. J Interv Cardiol. 2020 Dec 9;2020:4794838. doi: 10.1155/2020/4794838. eCollection 2020.
PubMed 33380922Tsigkas G, Papageorgiou A, Moulias A, Kalogeropoulos AP, Papageorgopoulou C, Apostolos A, Papanikolaou A, Vasilagkos G, Davlouros P. Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):22-32. doi: 10.1016/j.jcin.2021.09.037. Epub 2021 Dec 15.
PubMed 34922888Chen T, Huang H, Li L, Yang A, Shi G, Li F, Lu W, Xu L, Cai G. Analysis of the diameter of the distal radial artery at anatomic snuffbox by ultrasonography in patients scheduled for coronary intervention. J Vasc Access. 2025 May;26(3):896-903. doi: 10.1177/11297298241250263. Epub 2024 May 16.
PubMed 38752401Lu W, Chen T, Wang H, Yang A, Li L, Shi G, Xue S, Li F, Xiao J, Gu J, Zhang L, Liang X, Li W, Cai G. Comparison of the Effect of a 6-French Glidesheath Slender and a Conventional Sheath on Distal Radial Artery Occlusion: A Randomized Controlled Trial. Can J Cardiol. 2024 Nov;40(11):2292-2300. doi: 10.1016/j.cjca.2024.07.011. Epub 2024 Jul 19.
PubMed 39032557Chen T, Li L, Yang A, Huang H, Shi G, Li F, Li W, Lu W, Xu L, Li L, Cai G. Incidence of Distal Radial Artery Occlusion and its Influencing Factors After Cardiovascular Intervention Via the Distal Transradial Access. J Endovasc Ther. 2025 Oct;32(5):1408-1416. doi: 10.1177/15266028231208638. Epub 2023 Oct 31.
PubMed 37906607Chen T, Li L, Li F, Lu W, Shi G, Li W, Yang A, Huang H, Xiao J, Zhang Q, Gu J, Xue S, Zhang L, Li L, Xu L, Ji R, Wang H, Cai G. Comparison of long-term radial artery occlusion via distal vs. conventional transradial access (CONDITION): a randomized controlled trial. BMC Med. 2024 Feb 8;22(1):62. doi: 10.1186/s12916-024-03281-7.
PubMed 38331793
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of 6-French Glidesheath Slender in Coronary Angiography and Percutaneous Coronary Intervention Via Distal Transradial Access in Patients With Small Vessels: A Single-Center, Adaptive, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07410364
- Acronym / sponsor ID
- DISTAL-SV / 2025-SR-229
- Conditions
- Coronary Artery Disease
- Keywords
- Distal radial artery, Small vessel, Ultrasound, Distal radial artery occlusion, Radial artery occlusion, Visual analog scale, Safety, Efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- Cai gaojun, MDUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 13 Feb 2026 (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.
Randomized controlled trial of adaptive design for the safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial access using a 6-French Glidesheath Slender in patients with small vessels.
Detailed description
The safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial access (dTRA) have been confirmed by a large number of studies, but there are still few studies on its safety and efficacy in patients with small vessels (distal radial artery diameter < 2.0mm). The 6-French Glidesheath Slender, with its smaller outer diameter, should be more suitable for patients with small vessels. To this end, we plan to conduct a single-center, adaptive, randomized controlled trial enrolling 594 patients aged 18-85 years old with distal radial artery diameters <2.0 mm and ≥1.0 mm who are scheduled to undergo coronary angiography and percutaneous coronary intervention via the distal radial artery approach in our center. The study employed a stratification-block randomized design. Stratification was performed based on patient gender, with a block size of 4 within each stratum. Eligible patients were randomly assigned in a 1:1 ratio to either the 6-French Glidesheath Slender group or the 6-French conventional sheath group.
The primary endpoint of the study was distal radial artery occlusion assessed by vascular ultrasound 24 hours postoperatively. Secondary endpoints included puncture success rate, procedure success rate, number of punctures, puncture time, total procedural time, visual analogue scale pain scores during sheath placement, bleeding, hematoma, arteriovenous fistula, finger numbness, and conventional radial artery occlusion at 24 hours postoperatively.
An interim analysis will be conducted when 50% of the total sample size (297 patients) is enrolled, with subsequent sample size adjustments based on preliminary study results.
The results of this study will provide evidence for the safety and efficacy of 6-French Glidesheath Slender for coronary angiography and percutaneous coronary intervention in patients with small vessels via distal transradial access, and provide information for the selection of the best sheath equipment for patients with small vessels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6-French Glidesheath Slender group | Experimental | Device: Performing coronary angiography and percutaneous coronary intervention via the distal transradial access in patients with small vessels (DRA < 2.0 mm) using a 6-Fr Glidesheath Slender sheath.Performing coronary angiography and percutaneous coronary intervention via the distal transradial access using a 6-French Glidesheath Slender sheath. |
| 6-F Conventional sheath group | Sham comparator | Device: Performing coronary interventional procedures via the distal radial artery in patients with small vessels ( DRA diameter < 2.0 mm ) using a 6-Fr Conventional sheath.Performing coronary angiography and percutaneous coronary intervention via the distal transradial access using a 6-F Conventional sheath. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 85 years
- Palpable pulses in both the distal radial artery and conventional radial artery
- All patients signed informed consent forms prior to procedure
Key exclusion criteria (7 listed)
- Ultrasound assessment of the distal radial artery diameter ≥2.0mm or <1.0mm
- Height ≥185.0cm
- Patients with acute ST-segment elevation myocardial infarction, cardiogenic shock, or hemodynamic instability
- Contraindications for puncture of the distal radial artery
- Patients with Raynaud's syndrome
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 |
|---|---|---|
| Performing coronary angiography and percutaneous coronary intervention via the distal transradial access in patients with small vessels (DRA < 2.0 mm) using a 6-Fr Glidesheath Slender sheath.Also: 6-French Glidesheath SlenderCoronary angiography and percutaneous coronary intervention was performed in participants with small vessels (DRA < 2.0 mm) via the distal transradial access using a 6-French Glidesheath Slender sheath. | Device | 6-French Glidesheath Slender group |
| Performing coronary interventional procedures via the distal radial artery in patients with small vessels ( DRA diameter < 2.0 mm ) using a 6-Fr Conventional sheath.Also: 6-Fr Conventional sheathCoronary angiography and percutaneous coronary intervention was performed in participants with small vessels (DRA < 2.0 mm) via the distal transradial access using a 6-French Conventional sheath. | Device | 6-F Conventional sheath group |
Primary outcome
Distal radial artery occlusion(dRAO)
Time frame: 24 hours postoperatively.
The dRAO is defined as the absence of blood flow in the distal radial artery assessed by the doppler ultrasound.
11 secondary outcomes
Puncture success
Time frame: Periprocedural
Procedure success
Time frame: Periprocedural
Number of punctures
Time frame: Periprocedural
Puncture time(second)
Time frame: Periprocedural
Procedural time(minute)
Time frame: Periprocedural
Visual Analogue Scale (VAS) pain scores(0-10) during sheath placement
Time frame: Periprocedural
Bleeding
Time frame: 24 hours postoperatively
Haematoma
Time frame: 24 hours postoperatively
Arteriovenous fistula
Time frame: 24 hours postoperatively.
Finger numbness
Time frame: 24 hours postoperatively
Conventional radial artery occlusion (cRAO)
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Results publication: PubMed 41478549Li F, Zhou T, Fan X, Chen T, Shi G, Li L, Cai G. Safety and Efficacy of Distal Transradial Access in Patients With Small Diameter Distal Radial Artery: A Post Hoc Analysis of 2 Randomized Trials. Can J Cardiol. 2026 Jun;42(6):1221-1229. doi: 10.1016/j.cjca.2025.12.048. Epub 2025 Dec 30.
- Results publication: PubMed 30088362Kim Y, Ahn Y, Kim I, Lee DH, Kim MC, Sim DS, Hong YJ, Kim JH, Jeong MH. Feasibility of Coronary Angiography and Percutaneous Coronary Intervention via Left Snuffbox Approach. Korean Circ J. 2018 Dec;48(12):1120-1130. doi: 10.4070/kcj.2018.0181. Epub 2018 Aug 6.
- Results publication: PubMed 33380922Lin Y, Sun X, Chen R, Liu H, Pang X, Chen J, Dong S. Feasibility and Safety of the Distal Transradial Artery for Coronary Diagnostic or Interventional Catheterization. J Interv Cardiol. 2020 Dec 9;2020:4794838. doi: 10.1155/2020/4794838. eCollection 2020.
- Results publication: PubMed 34922888Tsigkas G, Papageorgiou A, Moulias A, Kalogeropoulos AP, Papageorgopoulou C, Apostolos A, Papanikolaou A, Vasilagkos G, Davlouros P. Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):22-32. doi: 10.1016/j.jcin.2021.09.037. Epub 2021 Dec 15.
- Results publication: PubMed 38752401Chen T, Huang H, Li L, Yang A, Shi G, Li F, Lu W, Xu L, Cai G. Analysis of the diameter of the distal radial artery at anatomic snuffbox by ultrasonography in patients scheduled for coronary intervention. J Vasc Access. 2025 May;26(3):896-903. doi: 10.1177/11297298241250263. Epub 2024 May 16.
- Results publication: PubMed 39032557Lu W, Chen T, Wang H, Yang A, Li L, Shi G, Xue S, Li F, Xiao J, Gu J, Zhang L, Liang X, Li W, Cai G. Comparison of the Effect of a 6-French Glidesheath Slender and a Conventional Sheath on Distal Radial Artery Occlusion: A Randomized Controlled Trial. Can J Cardiol. 2024 Nov;40(11):2292-2300. doi: 10.1016/j.cjca.2024.07.011. Epub 2024 Jul 19.
- Results publication: PubMed 37906607Chen T, Li L, Yang A, Huang H, Shi G, Li F, Li W, Lu W, Xu L, Li L, Cai G. Incidence of Distal Radial Artery Occlusion and its Influencing Factors After Cardiovascular Intervention Via the Distal Transradial Access. J Endovasc Ther. 2025 Oct;32(5):1408-1416. doi: 10.1177/15266028231208638. Epub 2023 Oct 31.
- Results publication: PubMed 38331793Chen T, Li L, Li F, Lu W, Shi G, Li W, Yang A, Huang H, Xiao J, Zhang Q, Gu J, Xue S, Zhang L, Li L, Xu L, Ji R, Wang H, Cai G. Comparison of long-term radial artery occlusion via distal vs. conventional transradial access (CONDITION): a randomized controlled trial. BMC Med. 2024 Feb 8;22(1):62. doi: 10.1186/s12916-024-03281-7.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
haiyan HY zhang, BS principal investigator
Wujin Hospital Affiliated with Jiangsu University.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performing coronary angiography and percutaneous coronary intervention via the distal transradial access in patients with small vessels (DRA < 2.0 mm) using a 6-Fr Glidesheath Slender sheath. and Performing coronary interventional procedures via the distal radial artery in patients with small vessels ( DRA diameter < 2.0 mm ) using a 6-Fr Conventional sheath. in people with Coronary Artery Disease, run by Cai gaojun, MD at 2 sites 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 19 May 2026. 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 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact gaojun GJ cai, PhD (+86 0519-85579192, caigaojun@wjrmyy.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distal radial artery occlusion(dRAO) (time frame: 24 hours postoperatively.). 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 NCT07410364, which also lists 8 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 19 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.