Coronary DiseasesNCT04641468
Clinical Efficacy and Safety of a Prospective, Multicenter Drug Coated Balloon for Left Main Artery Disease in China
A study testing DCB in people with Coronary Diseases and Left Main Coronary Artery Disease, run by Xuzhou Third People's Hospital at 1 site in China.
Trial summary
This is a prospective and observational study. Patients with primary mediana 010 or 001 left main bifurcation lesions were treated with drug ball coated balloon from November 2018 to November 2020 in four hospitals in Huaihai area. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Diseases, Left Main Coronary Artery Disease, Bifurcation Lesions
- What is being tested?
- DCB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 31 Dec 2021
- 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
- Male or non pregnant women aged 18-75 years old;
- There is clear evidence of myocardial ischemia, including typical ECG changes, non ST segment elevation acute coronary syndrome, ST segment elevation acute myocardial infarction, etc;
- For mediana 010 or 001 confirmed by coronary angiography, the stenosis was more than 70% by visual inspection and less than 30% at the end of left main artery;
- They can receive DCB treatment;
- The reference vessel diameter was 2.00 ~ 4.00 mm;
- To understand the potential risk of operation and have the intention of DCB treatment.
Who cannot join
- Hemodynamic instability, unable to tolerate surgery;
- The left ventricular ejection fraction was less than 35%;
- Contrast medium allergy or contraindication for secondary prevention of coronary heart disease;
- Stents were implanted in the left main trunk;
- Severe renal insufficiency (EGFR ≤ 30 ml / min / 1.73 m2);
- Severe infection;
- Life expectancy is less than one year. All patients signed the informed consent of interventional therapy before operation, and this study was approved by hospital ethics committee.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuzhou Third People's Hospital
Xuzhou, Jiangsu, 221000
fengjiao huang, master, +86-13685102194, 13685102194@qq.com
About this study
This is a prospective and observational study. Patients with primary mediana 010 or 001 left main bifurcation lesions were treated with drug ball coated balloon from November 2018 to November 2020 in four hospitals in Huaihai area. The clinical characteristics, pathological changes, operation process and perioperative drug treatment data were collected. Clinical follow-up included hospitalization, postoperative telephone or outpatient follow-up. Objective to compare the safety and efficacy of drug-eluting balloon and drug-eluting stent implantation alone in the treatment of primary mediana 010 or 001 left main bifurcation lesions.
Read the detailed description
At present, the primary left main trunk end bifurcation lesions with mediana classification of 010 or 001 are mainly treated by crossing stent technique or direct precise positioning stent technology. Because of the difficulty of precise stent placement, the displacement of cristae across stent implantation is easy to affect the distal vessels of the side branch or main branch, and the long-term clinical efficacy is not good, so the standardized interventional therapy is still controversial. Recently, a registered study published by regatelli et al. Showed that spanning stent technology seems to be superior to precise positioning stent technology, but the major adverse cardiac event rate in clinical follow-up is high.
Drug coated balloon (DCB) as a new interventional therapy in recent years, has been gradually used in the treatment of primary coronary artery disease in situ. The latest international consensus on the treatment of coronary heart disease with DCB indicates that more and more clinical studies have shown the safety and effectiveness of DCB in the treatment of coronary artery disease (≥ 3.0 mm). However, there are few studies on the interventional therapy of DCB in the primary mediana type 010 or 001 left trunk end bifurcation lesions, especially the combination of "1-2mm" drug-eluting stent (DES) implantation when necessary.
The purpose of this study was to investigate the feasibility and short-term clinical efficacy of DCB combined with DES implantation in the treatment of primary mediana 010 or 001 left main bifurcation lesions, and to explore a new treatment for such lesions.
- Being tested
- DCB
- Keywords
- DCB, left main trunk, Bifurcation lesions
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCBProcedure or surgery
Also called optical coherence tomography
OCT technical guidance: if B-type or C-type dissection can be seen, Oct should be used for further evaluation, and des treatment should be conducted if necessary
| Study group | Role | What they receive |
|---|---|---|
| Mediana 010 or 001 left main bifurcation lesion | Other | DCB alone combined with retracted DES implantation if necessary (d-p-d strategy) Receives: Procedure: DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patients were followed up for 12 months to observe the major adverse cardiac events (MACE)
There were three endpoints: cardiovascular death, myocardial infarction and stroke
Measured: 12 months after operation
Secondary outcomes (2)
Incidence of target lesion revascularization
Target lesion revascularization
Measured: 12 months after operation
All revascularization rates
All revascularization
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Nov 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseasesStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Third People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yaojun zhang, doctor, Principal investigator, Head of Cardiology Department of Xuzhou Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641468
- Sponsor's protocol ID
- 2019-02-002-K01
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.
PubMed 8041414Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.
PubMed 8041413Gruchalla KJ, Nawarskas JJ. The paclitaxel-eluting stent in percutaneous coronary intervention: part I: background and clinical comparison to bare metal stents. Cardiol Rev. 2006 Mar-Apr;14(2):88-98. doi: 10.1097/01.crd.0000200895.60631.0b.
PubMed 16493246Navarese EP, Austin D, Gurbel PA, Andreotti F, Tantry U, James S, Buffon A, Kozinski M, Obonska K, Bliden K, Jeong YH, Kubica J, Kunadian V. Drug-coated balloons in treatment of in-stent restenosis: a meta-analysis of randomised controlled trials. Clin Res Cardiol. 2013 Apr;102(4):279-87. doi: 10.1007/s00392-012-0532-3. Epub 2012 Dec 20.
PubMed 23262495Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med. 2006 Dec;119(12):1056-61. doi: 10.1016/j.amjmed.2006.01.023.
PubMed 17145250Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.
PubMed 17869634Hassan AK, Bergheanu SC, Stijnen T, van der Hoeven BL, Snoep JD, Plevier JW, Schalij MJ, Wouter Jukema J. Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis. Eur Heart J. 2010 May;31(10):1172-80. doi: 10.1093/eurheartj/ehn553. Epub 2009 Jan 21.
PubMed 19158118Chang M, Park DW. Optimal Duration of Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents: Shorter or Longer? Cardiol Ther. 2014 Dec;3(1-2):1-12. doi: 10.1007/s40119-014-0030-y. Epub 2014 Nov 1.
PubMed 25367504De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nuesch E, Juni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1.
PubMed 25176289
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of a Prospective, Multicenter Drug Coated Balloon for Left Main Artery Disease in China
- ClinicalTrials.gov ID
- NCT04641468
- Acronym / sponsor ID
- 2019-02-002-K01
- Keywords
- DCB, left main trunk, Bifurcation lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xuzhou Third People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Nov 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.
This is a prospective and observational study. Patients with primary mediana 010 or 001 left main bifurcation lesions were treated with drug ball coated balloon from November 2018 to November 2020 in four hospitals in Huaihai area. The clinical characteristics, pathological changes, operation process and perioperative drug treatment data were collected. Clinical follow-up included hospitalization, postoperative telephone or outpatient follow-up. Objective to compare the safety and efficacy of drug-eluting balloon and drug-eluting stent implantation alone in the treatment of primary mediana 010 or 001 left main bifurcation lesions.
Detailed description
At present, the primary left main trunk end bifurcation lesions with mediana classification of 010 or 001 are mainly treated by crossing stent technique or direct precise positioning stent technology. Because of the difficulty of precise stent placement, the displacement of cristae across stent implantation is easy to affect the distal vessels of the side branch or main branch, and the long-term clinical efficacy is not good, so the standardized interventional therapy is still controversial. Recently, a registered study published by regatelli et al. Showed that spanning stent technology seems to be superior to precise positioning stent technology, but the major adverse cardiac event rate in clinical follow-up is high.
Drug coated balloon (DCB) as a new interventional therapy in recent years, has been gradually used in the treatment of primary coronary artery disease in situ. The latest international consensus on the treatment of coronary heart disease with DCB indicates that more and more clinical studies have shown the safety and effectiveness of DCB in the treatment of coronary artery disease (≥ 3.0 mm). However, there are few studies on the interventional therapy of DCB in the primary mediana type 010 or 001 left trunk end bifurcation lesions, especially the combination of "1-2mm" drug-eluting stent (DES) implantation when necessary.
The purpose of this study was to investigate the feasibility and short-term clinical efficacy of DCB combined with DES implantation in the treatment of primary mediana 010 or 001 left main bifurcation lesions, and to explore a new treatment for such lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mediana 010 or 001 left main bifurcation lesion | Other | Procedure: DCBDCB alone combined with retracted DES implantation if necessary (d-p-d strategy) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non pregnant women aged 18-75 years old;
- There is clear evidence of myocardial ischemia, including typical ECG changes, non ST segment elevation acute coronary syndrome, ST segment elevation acute myocardial infarction, etc;
- For mediana 010 or 001 confirmed by coronary angiography, the stenosis was more than 70% by visual inspection and less than 30% at the end of left main artery;
- They can receive DCB treatment;
- The reference vessel diameter was 2.00 ~ 4.00 mm;
Key exclusion criteria (7 listed)
- Hemodynamic instability, unable to tolerate surgery;
- The left ventricular ejection fraction was less than 35%;
- Contrast medium allergy or contraindication for secondary prevention of coronary heart disease;
- Stents were implanted in the left main trunk;
- Severe renal insufficiency (EGFR ≤ 30 ml / min / 1.73 m2);
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 |
|---|---|---|
| DCBAlso: optical coherence tomographyOCT technical guidance: if B-type or C-type dissection can be seen, Oct should be used for further evaluation, and des treatment should be conducted if necessary | Procedure or surgery | Mediana 010 or 001 left main bifurcation lesion |
Primary outcome
The patients were followed up for 12 months to observe the major adverse cardiac events (MACE)
Time frame: 12 months after operation
There were three endpoints: cardiovascular death, myocardial infarction and stroke
2 secondary outcomes
Incidence of target lesion revascularization
Time frame: 12 months after operation
All revascularization rates
Time frame: 12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Results publication: PubMed 8041414Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.
- Results publication: PubMed 8041413Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.
- Results publication: PubMed 16493246Gruchalla KJ, Nawarskas JJ. The paclitaxel-eluting stent in percutaneous coronary intervention: part I: background and clinical comparison to bare metal stents. Cardiol Rev. 2006 Mar-Apr;14(2):88-98. doi: 10.1097/01.crd.0000200895.60631.0b.
- Results publication: PubMed 23262495Navarese EP, Austin D, Gurbel PA, Andreotti F, Tantry U, James S, Buffon A, Kozinski M, Obonska K, Bliden K, Jeong YH, Kubica J, Kunadian V. Drug-coated balloons in treatment of in-stent restenosis: a meta-analysis of randomised controlled trials. Clin Res Cardiol. 2013 Apr;102(4):279-87. doi: 10.1007/s00392-012-0532-3. Epub 2012 Dec 20.
- Results publication: PubMed 17145250Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med. 2006 Dec;119(12):1056-61. doi: 10.1016/j.amjmed.2006.01.023.
- Results publication: PubMed 17869634Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.
- Results publication: PubMed 19158118Hassan AK, Bergheanu SC, Stijnen T, van der Hoeven BL, Snoep JD, Plevier JW, Schalij MJ, Wouter Jukema J. Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis. Eur Heart J. 2010 May;31(10):1172-80. doi: 10.1093/eurheartj/ehn553. Epub 2009 Jan 21.
- Results publication: PubMed 25367504Chang M, Park DW. Optimal Duration of Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents: Shorter or Longer? Cardiol Ther. 2014 Dec;3(1-2):1-12. doi: 10.1007/s40119-014-0030-y. Epub 2014 Nov 1.
- Results publication: PubMed 25176289De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nuesch E, Juni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1.
- 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, doctor principal investigator
Head of Cardiology Department of Xuzhou Third People'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 DCB in people with Coronary Diseases and Left Main Coronary Artery Disease, run by Xuzhou Third People's Hospital 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 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: status not confirmed, as of the sponsor's last update on 27 Nov 2020. 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?
Contact fengjiao huang, Master (+86-13685102194, 13685102194@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patients were followed up for 12 months to observe the major adverse cardiac events (MACE) (time frame: 12 months after operation). 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 NCT04641468, which also lists 9 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 Nov 2020.