Coronary Artery DiseasePROVISIONDEBNCT06002932
Comparison of PROVISIONal 1-stent Strategy with DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
A study testing Procedure: planed 2-stent strategy and Procedure: provisional 1-stent plus DEB strategy in people with Coronary Artery Disease and Ischemic Heart Disease, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
Trial summary
[The Purpose of the Clinical Study] The purpose of this randomized comparison study is to compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients with non-LM coronary true-bifurcation lesions. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease
- What is being tested?
- Procedure: planed 2-stent strategy and Procedure: provisional 1-stent plus DEB strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Sep 2023to 31 Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ① 19+ years old
- ② Patients with the following lesions and clinical factors. 2-1. The lesion factor: Visually confirmed diameter of the 2.25-2.75 mm in branched vessels, where the main blood vessel's diameter is at least 2.5 mm; the lesion at the branched vessels is of a Medina classification (1,1,1), (1,0,1), or (0,1,1), with a true bifurcation; a de novo lesion.
- 2-2 Clinical factors: Stable angina pectoris, unstable angina pectoris, or myocardial infarction with an elevated non-ST segment, all at least 24 hours after their last treatment.
- ③ Patients who understood the definitions of the test group and the control group and the risks involved in the treatment, and with voluntary, informed consent to participate in the study, as provided either by the patient or their legal representatives.
Who cannot join
- Patients with myocardial infarction involving an elevated ST segment, or patients with an LM coronary true-bifurcation lesion.
- Patients who are ruled out by the treatment provider because the 2-stent strategy was deemed unsuitable to the patient due to a clinical condition.
- A patient with aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel) contraindications.
- A patient who experienced psychogenic shock at the time of admission, or showed severe left ventricle insufficiency (where the left ventricle ejection fraction is less than 30%.)
- A patient who requires prolonged anti-coagulative treatment (warfarin or a new oral anti-coagulant [NOAC])
- A patient who is currently hemorrhagic, or has a high risk of major hemorrhage (active peptic ulcer, GI lesions with high hemorrhagic risks, malicious tumors with a high risk of hemorrhage) ⑦ A patient with a history of intra-cerebral hemorrhage or intra-cerebral aneurysm.
Show all 13Show fewer
- A patient for whom surgery that requires antiplatelet treatment intervention is scheduled within the next six months.
- ⑨ A patient with severe hepatic diseases (abdominal effusion) Platelet count at less than 80,000 cells/mm3 Hgb count at less than 10 g/dL
- ⑩ A patient who appears to be at risk of bradycardia (a patient with an insufficiency of the said function, or a patient without a permanent pacemaker despite a grade 2 or higher atrioventricular block).
- ⑪ A patient who tested positive in a pregnancy test, or is currently breastfeeding
- ⑫ A patient with less than one year of remaining life expectancy due to comorbidity (based on the medical judgment of the investigator).
- ⑬ A patient who is already participating in another randomized clinical study for other medicines or medical devices, where the primary end point has not been reached.
- ⑭ A patient who did not sign her informed consent form, or could not be traced in the long-term.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
St. Vincent's Hospital , the Catholic University
Suwon, Gyeonggi-do, 16247
Sung-Ho Her, MD. PhD., +82312598397, hhhsungho@naver.com
Kyusup Lee, MD. PhD., +821090590389, ajobi7121@gmail.com
About this study
Official title: Comparison of PROVISIONal 1-stent Strategy with Drug-Eluting Balloon Versus Planned 2-stent Strategy in Patients with Non-LM Coronary True-Bifurcation Lesions.
[The Purpose of the Clinical Study] The purpose of this randomized comparison study is to compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients with non-LM coronary true-bifurcation lesions.
[Hypothesis] In this study, the researchers intend to verify the hypothesis that the 1-stent strategy with a drug-eluting balloon is non-inferior to the 2-stent strategy in terms of target lesion failures (cardiac death, target vessel MI, or target vessel revascularization).
Read the detailed description
- Provisional 1-stent plus DEB strategy As a principal, the treatment regime will be composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a branch vessel. The order of the treatments done to the main vessel and the branch vessel shall be at the discretion of the treatment provider. Also, at the discretion of the treatment provider, a bail-out stenting can still be performed, depending on the condition of the branch vessel following a drug-eluting balloon treatment. However, bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or significant residual stenosis.
- Planned 2-stent strategy As per the conventional treatment process, this strategy treats both the main vessel and the branch vessel with stents. The decision among Crush (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the treatment provider.
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease
- Being tested
- Procedure: planed 2-stent strategy, Procedure: provisional 1-stent plus DEB strategy
- Keywords
- coronary artery disease, percutaneous coronary intervention, coronary bifurcation lesion, strategy
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: planed 2-stent strategyProcedure or surgery
Procedure: planed 2-stent strategy
Procedure: provisional 1-stent plus DEB strategyProcedure or surgery
Procedure: provisional 1-stent plus DEB strategy
| Study group | Role | What they receive |
|---|---|---|
| Conventional arm | Active comparator | As per the conventional treatment process, this strategy treats both the main vessel and the branch vessel with stents. The decision among Crush (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the treatment provider. Receives: Procedure: Procedure: planed 2-stent strategy |
| PROVISION-DEB arm | Experimental | As a principal, the treatment regime will be composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a branch vessel. The order of the treatments done to the main vessel and the branch vessel shall be at the discretion of the treatment provider. Also, at the discretion of the treatment provider, a bail-out stenting can still be performed, depending on the condition of the branch vessel following a drug-eluting balloon treatment. However, bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or significant residual stenosis. Receives: Procedure: Procedure: provisional 1-stent plus DEB strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
target lesion failure the number of events
composite outcomes the number of events (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization)
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start8 Sep 2023
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intervention
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Vincent's Hospital, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sung-Ho Her, MD. PhD., Principal investigator, St Vincent's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002932
- Sponsor's protocol ID
- XC22EIDI0051
- Acronym
- PROVISIONDEB
- Status last verified
- Feb 2025
- First submitted
- 31 Jul 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PROVISIONal 1-stent Strategy with Drug-Eluting Balloon Versus Planned 2-stent Strategy in Patients with Non-LM Coronary True-Bifurcation Lesions.
- ClinicalTrials.gov ID
- NCT06002932
- Acronym / sponsor ID
- PROVISIONDEB / XC22EIDI0051
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease
- Keywords
- coronary artery disease, percutaneous coronary intervention, coronary bifurcation lesion, strategy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Saint Vincent's Hospital, KoreaUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Aug 2023 (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.
[The Purpose of the Clinical Study] The purpose of this randomized comparison study is to compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients with non-LM coronary true-bifurcation lesions.
[Hypothesis] In this study, the researchers intend to verify the hypothesis that the 1-stent strategy with a drug-eluting balloon is non-inferior to the 2-stent strategy in terms of target lesion failures (cardiac death, target vessel MI, or target vessel revascularization).
Detailed description
- Provisional 1-stent plus DEB strategy As a principal, the treatment regime will be composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a branch vessel. The order of the treatments done to the main vessel and the branch vessel shall be at the discretion of the treatment provider. Also, at the discretion of the treatment provider, a bail-out stenting can still be performed, depending on the condition of the branch vessel following a drug-eluting balloon treatment. However, bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or significant residual stenosis.
- Planned 2-stent strategy As per the conventional treatment process, this strategy treats both the main vessel and the branch vessel with stents. The decision among Crush (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the treatment provider.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention
| Arm | Type | Receives |
|---|---|---|
| Conventional arm | Active comparator | Procedure: Procedure: planed 2-stent strategyAs per the conventional treatment process, this strategy treats both the main vessel and the branch vessel with stents. The decision among Crush (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the treatment provider. |
| PROVISION-DEB arm | Experimental | Procedure: Procedure: provisional 1-stent plus DEB strategyAs a principal, the treatment regime will be composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a branch vessel. The order of the treatments done to the main vessel and the branch vessel shall be at the discretion of the treatment provider. Also, at the discretion of the treatment provider, a bail-out stenting can still be performed, depending on the condition of the branch vessel following a drug-eluting balloon treatment. However, bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or significant residual stenosis. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ① 19+ years old
- ② Patients with the following lesions and clinical factors. 2-1. The lesion factor: Visually confirmed diameter of the 2.25-2.75 mm in branched vessels, where the main blood vessel's diameter is at least 2.5 mm; the lesion at the branched vessels is of a Medina classification (1,1,1), (1,0,1), or (0,1,1), with a true bifurcation; a de novo lesion.
- 2-2 Clinical factors: Stable angina pectoris, unstable angina pectoris, or myocardial infarction with an elevated non-ST segment, all at least 24 hours after their last treatment.
- ③ Patients who understood the definitions of the test group and the control group and the risks involved in the treatment, and with voluntary, informed consent to participate in the study, as provided either by the patient or their legal representatives.
Key exclusion criteria (13 listed)
- Patients with myocardial infarction involving an elevated ST segment, or patients with an LM coronary true-bifurcation lesion.
- ⑨ A patient with severe hepatic diseases (abdominal effusion) Platelet count at less than 80,000 cells/mm3 Hgb count at less than 10 g/dL
- ⑩ A patient who appears to be at risk of bradycardia (a patient with an insufficiency of the said function, or a patient without a permanent pacemaker despite a grade 2 or higher atrioventricular block).
- ⑪ A patient who tested positive in a pregnancy test, or is currently breastfeeding
- ⑫ A patient with less than one year of remaining life expectancy due to comorbidity (based on the medical judgment of the investigator).
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 |
|---|---|---|
| Procedure: planed 2-stent strategyProcedure: planed 2-stent strategy | Procedure or surgery | Conventional arm |
| Procedure: provisional 1-stent plus DEB strategyProcedure: provisional 1-stent plus DEB strategy | Procedure or surgery | PROVISION-DEB arm |
Primary outcome
target lesion failure the number of events
Time frame: 12 months after randomization
composite outcomes the number of events (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization)
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 10 Feb 2025.
- 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.
Sung-Ho Her, MD. PhD. principal investigator
St Vincent's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: planed 2-stent strategy and Procedure: provisional 1-stent plus DEB strategy in people with Coronary Artery Disease and Ischemic Heart Disease, run by Saint Vincent's Hospital, Korea at 1 site 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 13 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 10 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 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?
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 Sung-Ho Her, MD. PhD. (+82312598397, hhhsungho@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target lesion failure the number of events (time frame: 12 months after randomization). 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 10 Feb 2025.