Coronary Artery DiseaseNCT06166459
Yao Strategy for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion
A study testing Drug-coated balloon combined with provisional drug-eluting stent implantation in people with Coronary Artery Disease and Bifurcation Lesion, run by Xuzhou Third People's Hospital.
Trial summary
Percutaneous coronary intervention for coronary bifurcation lesions represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Bifurcation Lesion
- What is being tested?
- Drug-coated balloon combined with provisional drug-eluting stent implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2024to 1 Mar 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
- Subjects at the age between ≥18 and ≤80 years old;
- De novo native lesion, Median type 010/001 bifurcation lesion;
- The reference diameter of the target vessel was 2.75-4.0mm and the length was less than 40mm;
- Subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up.
Who cannot join
- The diameter stenosis of adjacent branch vessel ostium ≥50%;
- Acute ST-segment elevation myocardial infarction;
- Stents implanted within 10 mm proximal or distal to the target lesion;
- Aneurysm within 10 mm proximal or distal to the target lesion;
- There is target vessel distortion or severe calcification lesion, so balloon catheter fails to pass;
- Previous coronary artery bypass grafting;
Show all 15Show fewer
- Evidence for extensive thrombus within target vessel;
- Evidence of heart failure by at least one of the following: a. Most recent LVEF ≤35%, or b. Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or c. Killip class ≥2 (post STEMI patients);
- Subjects with a life expectancy of ≤1 year;
- Subjects with stroke, peptic ulcer, or gastrointestinal bleeding within the past 6 months;
- Subjects with severe renal failure (eGFR<30ml/minute), failure to comply with angiography conditions;
- Subjects who are intolerance to aspirin and/or clopidogrel or ticagrelor or have contraindications;
- Subjects who are intolerance or allergic to heparin, contrast agent;
- Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
- Subjects who are not applicable to be enrolled by investigators due to other reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Drug-coated Balloon Combined With Provisional Drug-eluting Stent Implantation (Yao Strategy) for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion
Percutaneous coronary intervention for coronary bifurcation lesions represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural complications. The study is designed to enroll 200 patients with acute or chronic coronary syndromes that meet the indications for intervention and with angiographic confirmed de novo Medina type 0,1,0 or 0,0,1 bifurcation lesion. In view of the potential risks of using DCB alone in the treatment of de novo bifurcation lesions, the following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy). The primary endpoint was late lumen loss and major adverse cardiovascular events.
- Conditions
- Coronary Artery Disease, Bifurcation Lesion
- Being tested
- Drug-coated balloon combined with provisional drug-eluting stent implantation
- Keywords
- drug-coated balloon, percutaneous coronary intervention, drug-eluting stent, Yao strategy
- 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.
Drug-coated balloon combined with provisional drug-eluting stent implantationProcedure or surgery
(1) DCB combined with provisional DES implantation 1-2 mm distally to the ostium lesion whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the ostium lesions followed by DCB treatment (DES+DCB strategy).
| Study group | Role | What they receive |
|---|---|---|
| Yao technique | Experimental | The following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy). Receives: Procedure: Drug-coated balloon combined with provisional drug-eluting stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
late lumen loss
post-procedural minimum lumen diameter minus follow-up minimum lumen diameter.
Measured: 9 months follow-up
major adverse cardiovascular events
include cardiac death, non-fatal myocardial infarction, and target lesion revascularization.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start22 Apr 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Third People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaojun Zhang, Dr, Study chair, Xuzhou Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166459
- Sponsor's protocol ID
- 2023-02-022-K01
- Status last verified
- Dec 2023
- First submitted
- 3 Dec 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Escarcega RO. What is the Optimal Technique for Ostial Left Anterior Descending Artery Lesions? Cardiovasc Revasc Med. 2019 Dec;20(12):1063-1064. doi: 10.1016/j.carrev.2019.10.003. Epub 2019 Oct 22. No abstract available.
PubMed 31669112Dishmon DA, Elhaddi A, Packard K, Gupta V, Fischell TA. High incidence of inaccurate stent placement in the treatment of coronary aorto-ostial disease. J Invasive Cardiol. 2011 Aug;23(8):322-6.
PubMed 21828393Hildick-Smith DJ, Shapiro LM. Ostial left anterior descending coronary artery stent positioning: partial preinflation prevents stent oscillation and facilitates accurate deployment. J Interv Cardiol. 2001 Aug;14(4):439-42. doi: 10.1111/j.1540-8183.2001.tb00355.x.
PubMed 12053499Cayli M, Elbasan Z, Gur M, Seker T, Ucar H, Kuloglu O, Sen O, Sahin DY, Kalkan GY. Modified flower petal technique in the treatment of Medina type 0,0,1 or 0,1,0 lesions. EuroIntervention. 2015 Nov;11(7):772-9. doi: 10.4244/EIJV11I7A154.
PubMed 26603986Gutierrez-Chico JL, Villanueva-Benito I, Villanueva-Montoto L, Vazquez-Fernandez S, Kleinecke C, Gielen S, Iniguez-Romo A. Szabo technique versus conventional angiographic placement in bifurcations 010-001 of Medina and in aorto-ostial stenting: angiographic and procedural results. EuroIntervention. 2010 Feb;5(7):801-8. doi: 10.4244/eijv5i7a134.
PubMed 20142194Chen GC, Lu XM, Song YM, Gyawail L, Geng ZH, Song MB, Qian DH, Zhang YP, Ni DC, He Y. A 3-year experience of a simple, novel technique for accurate ostial/non-ostial coronary stenting: The buddy balloon anchor stent technique. Catheter Cardiovasc Interv. 2018 Nov 15;92(6):1147-1152. doi: 10.1002/ccd.27667. Epub 2018 Jul 18.
PubMed 30019847Yang ZK, Hu J, Ding FH, Ni JW, Zhang RY, Shen WF. One-year outcome of single-stent crossover versus accurate ostial stenting for isolated left anterior descending ostial stenosis. Coron Artery Dis. 2022 Jan 1;31(1):e67-e72. doi: 10.1097/MCA.0000000000001071.
PubMed 34010192Elkhateeb O, Thambi S, Beydoun H, Bishop H, Quraishi A, Kidwai B, Title L. Long-term outcomes following ostial left anterior descending artery intervention with or without crossover to left-main. Am J Cardiovasc Dis. 2022 Apr 15;12(2):73-80. eCollection 2022.
PubMed 35600287Vaquerizo B, Fernandez-Nofreiras E, Oategui I, Suarez de Lezo J, Rumoroso JR, Martin P, Routledge H, Tizon-Marcos H. Second-Generation Drug-Eluting Balloon for Ostial Side Branch Lesions (001-Bifurcations): Mid-Term Clinical and Angiographic Results. J Interv Cardiol. 2016 Jun;29(3):285-92. doi: 10.1111/joic.12292.
PubMed 27245124Erdogan E, Li Z, Zhu YX, Tufaro V, Feng SL, Li Q, Liang L, Chang S, Bu LT, Liu B, Zhou QH, Yap NAL, Bourantas CV, Zhang YJ. DCB combined with provisional DES implantation in the treatment of De Novo Medina 0,1,0 or 0,0,1 left main coronary bifurcation lesions: A proof-of-concept study. Anatol J Cardiol. 2022 Mar;26(3):218-225. doi: 10.5152/AnatolJCardiol.2021.1157.
PubMed 35346908
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-coated Balloon Combined With Provisional Drug-eluting Stent Implantation (Yao Strategy) for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion
- ClinicalTrials.gov ID
- NCT06166459
- Acronym / sponsor ID
- 2023-02-022-K01
- Conditions
- Coronary Artery Disease, Bifurcation Lesion
- Keywords
- drug-coated balloon, percutaneous coronary intervention, drug-eluting stent, Yao strategy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuzhou Third People's HospitalUniversity, hospital or other
- Study start
- 22 Apr 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 12 Dec 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.
Percutaneous coronary intervention for coronary bifurcation lesions represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural complications. The study is designed to enroll 200 patients with acute or chronic coronary syndromes that meet the indications for intervention and with angiographic confirmed de novo Medina type 0,1,0 or 0,0,1 bifurcation lesion. In view of the potential risks of using DCB alone in the treatment of de novo bifurcation lesions, the following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy). The primary endpoint was late lumen loss and major adverse cardiovascular events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yao technique | Experimental | Procedure: Drug-coated balloon combined with provisional drug-eluting stent implantationThe following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects at the age between ≥18 and ≤80 years old;
- De novo native lesion, Median type 010/001 bifurcation lesion;
- The reference diameter of the target vessel was 2.75-4.0mm and the length was less than 40mm;
- Subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up.
Key exclusion criteria (15 listed)
- The diameter stenosis of adjacent branch vessel ostium ≥50%;
- Acute ST-segment elevation myocardial infarction;
- Stents implanted within 10 mm proximal or distal to the target lesion;
- Aneurysm within 10 mm proximal or distal to the target lesion;
- There is target vessel distortion or severe calcification lesion, so balloon catheter fails to pass;
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 |
|---|---|---|
| Drug-coated balloon combined with provisional drug-eluting stent implantation(1) DCB combined with provisional DES implantation 1-2 mm distally to the ostium lesion whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the ostium lesions followed by DCB treatment (DES+DCB strategy). | Procedure or surgery | Yao technique |
Primary outcome
late lumen loss
Time frame: 9 months follow-up
post-procedural minimum lumen diameter minus follow-up minimum lumen diameter.
major adverse cardiovascular events
Time frame: 1 year
include cardiac death, non-fatal myocardial infarction, and target lesion revascularization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Background: PubMed 31669112Escarcega RO. What is the Optimal Technique for Ostial Left Anterior Descending Artery Lesions? Cardiovasc Revasc Med. 2019 Dec;20(12):1063-1064. doi: 10.1016/j.carrev.2019.10.003. Epub 2019 Oct 22. No abstract available.
- Background: PubMed 21828393Dishmon DA, Elhaddi A, Packard K, Gupta V, Fischell TA. High incidence of inaccurate stent placement in the treatment of coronary aorto-ostial disease. J Invasive Cardiol. 2011 Aug;23(8):322-6.
- Background: PubMed 12053499Hildick-Smith DJ, Shapiro LM. Ostial left anterior descending coronary artery stent positioning: partial preinflation prevents stent oscillation and facilitates accurate deployment. J Interv Cardiol. 2001 Aug;14(4):439-42. doi: 10.1111/j.1540-8183.2001.tb00355.x.
- Background: PubMed 26603986Cayli M, Elbasan Z, Gur M, Seker T, Ucar H, Kuloglu O, Sen O, Sahin DY, Kalkan GY. Modified flower petal technique in the treatment of Medina type 0,0,1 or 0,1,0 lesions. EuroIntervention. 2015 Nov;11(7):772-9. doi: 10.4244/EIJV11I7A154.
- Background: PubMed 20142194Gutierrez-Chico JL, Villanueva-Benito I, Villanueva-Montoto L, Vazquez-Fernandez S, Kleinecke C, Gielen S, Iniguez-Romo A. Szabo technique versus conventional angiographic placement in bifurcations 010-001 of Medina and in aorto-ostial stenting: angiographic and procedural results. EuroIntervention. 2010 Feb;5(7):801-8. doi: 10.4244/eijv5i7a134.
- Background: PubMed 30019847Chen GC, Lu XM, Song YM, Gyawail L, Geng ZH, Song MB, Qian DH, Zhang YP, Ni DC, He Y. A 3-year experience of a simple, novel technique for accurate ostial/non-ostial coronary stenting: The buddy balloon anchor stent technique. Catheter Cardiovasc Interv. 2018 Nov 15;92(6):1147-1152. doi: 10.1002/ccd.27667. Epub 2018 Jul 18.
- Background: PubMed 34010192Yang ZK, Hu J, Ding FH, Ni JW, Zhang RY, Shen WF. One-year outcome of single-stent crossover versus accurate ostial stenting for isolated left anterior descending ostial stenosis. Coron Artery Dis. 2022 Jan 1;31(1):e67-e72. doi: 10.1097/MCA.0000000000001071.
- Background: PubMed 35600287Elkhateeb O, Thambi S, Beydoun H, Bishop H, Quraishi A, Kidwai B, Title L. Long-term outcomes following ostial left anterior descending artery intervention with or without crossover to left-main. Am J Cardiovasc Dis. 2022 Apr 15;12(2):73-80. eCollection 2022.
- Background: PubMed 27245124Vaquerizo B, Fernandez-Nofreiras E, Oategui I, Suarez de Lezo J, Rumoroso JR, Martin P, Routledge H, Tizon-Marcos H. Second-Generation Drug-Eluting Balloon for Ostial Side Branch Lesions (001-Bifurcations): Mid-Term Clinical and Angiographic Results. J Interv Cardiol. 2016 Jun;29(3):285-92. doi: 10.1111/joic.12292.
- Background: PubMed 35346908Erdogan E, Li Z, Zhu YX, Tufaro V, Feng SL, Li Q, Liang L, Chang S, Bu LT, Liu B, Zhou QH, Yap NAL, Bourantas CV, Zhang YJ. DCB combined with provisional DES implantation in the treatment of De Novo Medina 0,1,0 or 0,0,1 left main coronary bifurcation lesions: A proof-of-concept study. Anatol J Cardiol. 2022 Mar;26(3):218-225. doi: 10.5152/AnatolJCardiol.2021.1157.
- Individual participant dataSharing planned: No
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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.
Yaojun Zhang, Dr study chair
Xuzhou Third People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Drug-coated balloon combined with provisional drug-eluting stent implantation in people with Coronary Artery Disease and Bifurcation Lesion, run by Xuzhou Third People's Hospital.
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 15 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 27 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaojun Zhang, Dr (+86-13770668667, 13770668667@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
late lumen loss (time frame: 9 months follow-up). 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 NCT06166459, which also lists 10 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 27 Mar 2024.