AngioplastyNCT04664283
Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
A study testing DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography in people with Angioplasty and Coronary Artery Disease, run by Liu Bin at 2 sites in China.
Trial summary
OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Angioplasty, Coronary Artery Disease
- What is being tested?
- DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years old Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, silent ischemia or myocardial infarction（≥1month） .
- Reference vessel diameter ≥3.0 mm, and <4.5mm. Lesion length of ≤20 mm Written informed consent
Who cannot join
- Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA=4，EF≤35%) Severe valvular heart disease Life expectancy no more than 1 year or factors causing difficulties in clinical follow up Intolerance to aspirin and/or clopidogrel, ticagrelor Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy Leukopenia or thrombopenia A history of peptic ulcer or GI bleeding in the previously Stroke within 6 months prior to the operation A history of severe hepatic or renal failure Stents covering a major side branch (≥2.5 mm need to intervention) Left main lesion Graft lesion Aortic-coronary ostial lesion In-stent restenotic lesion Chronic total occlusion Severe calcified lesions. Visible angiographic thrombus
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Second Hospital of Jilin University
Changchun, Jilin, 130041
the Second hospital of Jilin University
Changchun, Jilin, 130041
jinpeng wang, doctor, 15526891295, jinpeng0865@sina.com
About this study
Official title: Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography：a Prospective Multi-center Randomized Controlled Trial
OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter randomized controlled study aims to evaluate the long-term efficacy and safety of paclitaxel coated balloon in the treatment of native large coronary arteries by OCT guided is not inferior to drug-eluting stent.
- Conditions
- Angioplasty, Coronary Artery Disease
- Being tested
- DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
- Keywords
- coronary heart disease, large coronary vessel, optical coherence tomography, Drug-coated Balloon, Drug-eluting Stent
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence TomographyDevice
Also called DES for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
DCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography
| Study group | Role | What they receive |
|---|---|---|
| DCB group by OCT guided | Experimental | Not described Receives: Device: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography |
| DES group by OCT guided | Active comparator | Not described Receives: Device: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
late lumen loss （LLL）
late lumen loss between DCB treated group and DES treated group evaluated by quantitative coronary analysis in patients with CHD
Measured: Follow-up coronary angiography at 12 months after the procedure
Secondary outcomes (2)
The incidence rate of device-related ischemic events
The incidence rate of device-related ischemic events including cardiovascular death, target vessel related myocardial infarction and ischemia-driven revascularization between DCB treated group and DES treated group
Measured: Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure
The incidence rate of patient-related ischemic events
TThe incidence rate of patient-related ischemic events including all myocardial infarction , any revascularization and all-cause death between DCB treated group and DES treated group
Measured: Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AngioplastyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Bin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Bin, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664283
- Sponsor's protocol ID
- second hospital of Jilin U
- Status last verified
- Dec 2020
- First submitted
- 5 Dec 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Y, Zhang YJ, Deng LX, Yin ZY, Hu T, Wang Q, Li Y, Li JY, Guo WY, Mou FJ, Tao L. 12-Month clinical results of drug-coated balloons for de novo coronary lesion in vessels exceeding 3.0 mm. Int J Cardiovasc Imaging. 2019 Apr;35(4):579-586. doi: 10.1007/s10554-018-1505-z. Epub 2019 Mar 30.
PubMed 30929102Cuculi F, Young M, Beeler R, Schoenenberger AW, Erne P. Good efficacy of drug-eluting balloons in a mixed population of patients with coronary artery disease. J Invasive Cardiol. 2012 Apr;24(4):151-3.
PubMed 22477748Lu W, Zhu Y, Han Z, Sun G, Qin X, Wang Z, Liu G, Xi W, Wang X, Pan L, Qiu C. Short-term outcomes from drug-coated balloon for coronary de novo lesions in large vessels. J Cardiol. 2019 Feb;73(2):151-155. doi: 10.1016/j.jjcc.2018.07.008. Epub 2018 Oct 23.
PubMed 30366637Yu X, Ji F, Xu F, Zhang W, Wang X, Lu D, Yang C, Wang F. Treatment of large de novo coronary lesions with paclitaxel-coated balloon only: results from a Chinese institute. Clin Res Cardiol. 2019 Mar;108(3):234-243. doi: 10.1007/s00392-018-1346-8. Epub 2018 Aug 3.
PubMed 30074078Lansky A, Wijns W, Xu B, Kelbaek H, van Royen N, Zheng M, Morel MA, Knaapen P, Slagboom T, Johnson TW, Vlachojannis G, Arkenbout KE, Holmvang L, Janssens L, Ochala A, Brugaletta S, Naber CK, Anderson R, Rittger H, Berti S, Barbato E, Toth GG, Maillard L, Valina C, Buszman P, Thiele H, Schachinger V, Baumbach A; TARGET All Comers Investigators. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial. Lancet. 2018 Sep 29;392(10153):1117-1126. doi: 10.1016/S0140-6736(18)31649-0. Epub 2018 Sep 3.
PubMed 30190206Cortese B, Silva Orrego P, Agostoni P, Buccheri D, Piraino D, Andolina G, Seregni RG. Effect of Drug-Coated Balloons in Native Coronary Artery Disease Left With a Dissection. JACC Cardiovasc Interv. 2015 Dec 28;8(15):2003-2009. doi: 10.1016/j.jcin.2015.08.029. Epub 2015 Nov 25.
PubMed 26627997Nishiyama N, Komatsu T, Kuroyanagi T, Fujikake A, Komatsu S, Nakamura H, Yamada K, Nakahara S, Kobayashi S, Taguchi I. Clinical value of drug-coated balloon angioplasty for de novo lesions in patients with coronary artery disease. Int J Cardiol. 2016 Nov 1;222:113-118. doi: 10.1016/j.ijcard.2016.07.156. Epub 2016 Jul 27.
PubMed 27494722
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography：a Prospective Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04664283
- Acronym / sponsor ID
- second hospital of Jilin U
- Conditions
- Angioplasty, Coronary Artery Disease
- Keywords
- coronary heart disease, large coronary vessel, optical coherence tomography, Drug-coated Balloon, Drug-eluting Stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Liu BinUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Dec 2020 (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.
OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter randomized controlled study aims to evaluate the long-term efficacy and safety of paclitaxel coated balloon in the treatment of native large coronary arteries by OCT guided is not inferior to drug-eluting stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB group by OCT guided | Experimental | Device: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography |
| DES group by OCT guided | Active comparator | Device: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 75 years old Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, silent ischemia or myocardial infarction（≥1month） .
- Reference vessel diameter ≥3.0 mm, and <4.5mm. Lesion length of ≤20 mm Written informed consent
Key exclusion criteria (1 listed)
- Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA=4，EF≤35%) Severe valvular heart disease Life expectancy no more than 1 year or factors causing difficulties in clinical follow up Intolerance to aspirin and/or clopidogrel, ticagrelor Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy Leukopenia or thrombopenia A history of peptic ulcer or GI bleeding in the previously Stroke within 6 months prior to the operation A history of severe hepatic or renal failure Stents covering a major side branch (≥2.5 mm need to intervention) Left main lesion Graft lesion Aortic-coronary ostial lesion In-stent restenotic lesion Chronic total occlusion Severe calcified lesions. Visible angiographic thrombus
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 |
|---|---|---|
| DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence TomographyAlso: DES for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence TomographyDCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography | Device | DCB group by OCT guided, DES group by OCT guided |
Primary outcome
late lumen loss （LLL）
Time frame: Follow-up coronary angiography at 12 months after the procedure
late lumen loss between DCB treated group and DES treated group evaluated by quantitative coronary analysis in patients with CHD
2 secondary outcomes
The incidence rate of device-related ischemic events
Time frame: Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure
The incidence rate of patient-related ischemic events
Time frame: Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Results publication: PubMed 30929102Liu Y, Zhang YJ, Deng LX, Yin ZY, Hu T, Wang Q, Li Y, Li JY, Guo WY, Mou FJ, Tao L. 12-Month clinical results of drug-coated balloons for de novo coronary lesion in vessels exceeding 3.0 mm. Int J Cardiovasc Imaging. 2019 Apr;35(4):579-586. doi: 10.1007/s10554-018-1505-z. Epub 2019 Mar 30.
- Results publication: PubMed 22477748Cuculi F, Young M, Beeler R, Schoenenberger AW, Erne P. Good efficacy of drug-eluting balloons in a mixed population of patients with coronary artery disease. J Invasive Cardiol. 2012 Apr;24(4):151-3.
- Results publication: PubMed 30366637Lu W, Zhu Y, Han Z, Sun G, Qin X, Wang Z, Liu G, Xi W, Wang X, Pan L, Qiu C. Short-term outcomes from drug-coated balloon for coronary de novo lesions in large vessels. J Cardiol. 2019 Feb;73(2):151-155. doi: 10.1016/j.jjcc.2018.07.008. Epub 2018 Oct 23.
- Results publication: PubMed 30074078Yu X, Ji F, Xu F, Zhang W, Wang X, Lu D, Yang C, Wang F. Treatment of large de novo coronary lesions with paclitaxel-coated balloon only: results from a Chinese institute. Clin Res Cardiol. 2019 Mar;108(3):234-243. doi: 10.1007/s00392-018-1346-8. Epub 2018 Aug 3.
- Results publication: PubMed 30190206Lansky A, Wijns W, Xu B, Kelbaek H, van Royen N, Zheng M, Morel MA, Knaapen P, Slagboom T, Johnson TW, Vlachojannis G, Arkenbout KE, Holmvang L, Janssens L, Ochala A, Brugaletta S, Naber CK, Anderson R, Rittger H, Berti S, Barbato E, Toth GG, Maillard L, Valina C, Buszman P, Thiele H, Schachinger V, Baumbach A; TARGET All Comers Investigators. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (TARGET All Comers): a multicentre, open-label, randomised non-inferiority trial. Lancet. 2018 Sep 29;392(10153):1117-1126. doi: 10.1016/S0140-6736(18)31649-0. Epub 2018 Sep 3.
- Results publication: PubMed 26627997Cortese B, Silva Orrego P, Agostoni P, Buccheri D, Piraino D, Andolina G, Seregni RG. Effect of Drug-Coated Balloons in Native Coronary Artery Disease Left With a Dissection. JACC Cardiovasc Interv. 2015 Dec 28;8(15):2003-2009. doi: 10.1016/j.jcin.2015.08.029. Epub 2015 Nov 25.
- Results publication: PubMed 27494722Nishiyama N, Komatsu T, Kuroyanagi T, Fujikake A, Komatsu S, Nakamura H, Yamada K, Nakahara S, Kobayashi S, Taguchi I. Clinical value of drug-coated balloon angioplasty for de novo lesions in patients with coronary artery disease. Int J Cardiol. 2016 Nov 1;222:113-118. doi: 10.1016/j.ijcard.2016.07.156. Epub 2016 Jul 27.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography in people with Angioplasty and Coronary Artery Disease, run by Liu Bin 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 2 inclusion and 1 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 11 Dec 2020. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
late lumen loss （LLL） (time frame: Follow-up coronary angiography at 12 months after the 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 NCT04664283, which also lists 7 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 11 Dec 2020.