Stable Angina PectorisNCT03155971
PCB for Long De Novo Lesions of Main Coronary Arteries (D-Lesion Long Trial)
A study testing Paclitaxel-Coated Balloon in people with Stable Angina Pectoris and Unstable Angina Pectoris, run by The People's Hospital of Liaoning Province at 1 site in China.
Trial summary
This study evaluates the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stable Angina Pectoris, Unstable Angina Pectoris
- What is being tested?
- Paclitaxel-Coated Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 Feb 2019
- 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
- a diagnosis of stable angina or unstable angina in hospitalized patients. Objective clinical evidence of ischemia (ECT, Exercise ECG, ECG ST-T changes) With CAG proven one vessel lesion（a lesion length of ≥ 20mm)；
- a lesion diameter stenosis >75% as evaluated by QCA with a reference diameter of ≥ 2.75 mm and ≤ 3.5 mm .
- a willingness or ability to provide informed consent，a willingness to receive telephone followed-up at postoperative 1 month, 3 month, 6 month, and an angiographic follow up at postoperative 9 month.
- a willingness to receive DCB angioplast or DES implantation.
Who cannot join
- Patients with acute myocardial infarction within 30 days；
- a previous history of severe valvular heart disease,severe hepatic and renal insufficiency；severe cardiac dysfunction with EF≤40%；
- advanced cancer with a life expectancy of <12 months；
- Patients with abnormal coagulation function, Contraindications for antiplatelet drugs or unable to tolerate antiplatelet therapy;
- Pregnant and lactating patients；
- Multiple vessels involvement or multiple lesions requiring intervention treatment,left main artery lesions and coronary artery bypass graft lesions；
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- Stent restenosis
- Thrombotic disease，severe calcified lesions（Judged by the operator， CAG showed class 2 or more severe calcified lesions），spontaneous dissection or ulcerative lesion，coronary ostial lesions (the lesion included should be an interval of greater than 3mm from the ostial of RCA or LAD)， severe angulated lesions（>45°）
- diameter of collateral vessel≥ 2.25 mm requiring interventional therapy,type 1 coronary lesions（Patients with diameter of collateral vessel< 2.25 mm， who were not treated with DCB dilatation were also eligible）.
Trial locations and contacts
1 site in 1 country.
China1 site
The People's Hospital of Liaoning Province
Shenyang, Liaoning, 110016
Aijie Hou
Xizhuang Bai
About this study
Official title: Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Long De Novo Lesions of Main Coronary Arteries
This study evaluates the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.
Read the detailed description
Paclitaxel-Coated Balloon Catheter is a new device in coronary disease, it can inhibit the proliferation of smooth muscle of coronary vessels by transitory contaction, without residual implantation.
More and more evidences have shown its efficacy and safety in diffuse small coronary disease, bifurcation disease and in-stent restenosis. But there are still seldom evidences in De Novo Lesions of Main Coronary Arteries.
PCB has used in some subgroup of many study but confused with in-stent renstenosis or small coronary disease. The investigators designed this study to evaluate the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.
- Conditions
- Stable Angina Pectoris, Unstable Angina Pectoris
- Being tested
- Paclitaxel-Coated Balloon
- Keywords
- Drug-Coated Balloon, Main Coronary Artery, De Novo Lesion
- Medical subject headings
- Angina, Stable, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-Coated BalloonDevice
Also called Drug-coated balloon (DCB)
SeQuent ® Please; B.Braun, Melsungen, Germany
| Study group | Role | What they receive |
|---|---|---|
| PCB group | Experimental | Prospective, single center, single-group clinical study. Interventions: Patients in the PCB group will be treated (angioplasted) with Paclitaxel-Coated Balloon (SeQuent ® Please; B.Braun, Melsungen, Germany) Receives: Device: Paclitaxel-Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
QCA late lumen loss
minimal lumen diameter at post-procedure minus minimal lumen diameter at 9 months follow-up measured by QCA(quantitative coronary angiography)
Measured: Immediately after the procedure and at 9 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Angina PectorisStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The People's Hospital of Liaoning Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhilin Miao, The People's Hospital of Liaoning Province
- Investigators
- Aijie Hou, Principal investigator, The People's Hospital of Liaoning Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155971
- Sponsor's protocol ID
- CTC-91919
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Long De Novo Lesions of Main Coronary Arteries
- ClinicalTrials.gov ID
- NCT03155971
- Acronym / sponsor ID
- CTC-91919
- Conditions
- Stable Angina Pectoris, Unstable Angina Pectoris
- Keywords
- Drug-Coated Balloon, Main Coronary Artery, De Novo Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The People's Hospital of Liaoning ProvinceUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 16 May 2017 (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 study evaluates the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.
Detailed description
Paclitaxel-Coated Balloon Catheter is a new device in coronary disease, it can inhibit the proliferation of smooth muscle of coronary vessels by transitory contaction, without residual implantation.
More and more evidences have shown its efficacy and safety in diffuse small coronary disease, bifurcation disease and in-stent restenosis. But there are still seldom evidences in De Novo Lesions of Main Coronary Arteries.
PCB has used in some subgroup of many study but confused with in-stent renstenosis or small coronary disease. The investigators designed this study to evaluate the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCB group | Experimental | Device: Paclitaxel-Coated BalloonProspective, single center, single-group clinical study. Interventions: Patients in the PCB group will be treated (angioplasted) with Paclitaxel-Coated Balloon (SeQuent ® Please; B.Braun, Melsungen, Germany) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of stable angina or unstable angina in hospitalized patients. Objective clinical evidence of ischemia (ECT, Exercise ECG, ECG ST-T changes) With CAG proven one vessel lesion（a lesion length of ≥ 20mm)；
- a lesion diameter stenosis >75% as evaluated by QCA with a reference diameter of ≥ 2.75 mm and ≤ 3.5 mm .
- a willingness or ability to provide informed consent，a willingness to receive telephone followed-up at postoperative 1 month, 3 month, 6 month, and an angiographic follow up at postoperative 9 month.
- a willingness to receive DCB angioplast or DES implantation.
Key exclusion criteria (9 listed)
- Patients with acute myocardial infarction within 30 days；
- a previous history of severe valvular heart disease,severe hepatic and renal insufficiency；severe cardiac dysfunction with EF≤40%；
- advanced cancer with a life expectancy of <12 months；
- Patients with abnormal coagulation function, Contraindications for antiplatelet drugs or unable to tolerate antiplatelet therapy;
- Pregnant and lactating patients；
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 |
|---|---|---|
| Paclitaxel-Coated BalloonAlso: Drug-coated balloon (DCB)SeQuent ® Please; B.Braun, Melsungen, Germany | Device | PCB group |
Primary outcome
QCA late lumen loss
Time frame: Immediately after the procedure and at 9 months follow-up
minimal lumen diameter at post-procedure minus minimal lumen diameter at 9 months follow-up measured by QCA(quantitative coronary angiography)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Aijie Hou principal investigator
The People's Hospital of Liaoning Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel-Coated Balloon in people with Stable Angina Pectoris and Unstable Angina Pectoris, run by The People's Hospital of Liaoning Province 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 4 inclusion and 9 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 16 May 2017. 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 Fei Xia (+8617702487875, xf19870421@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QCA late lumen loss (time frame: Immediately after the procedure and at 9 months follow-up). 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 16 May 2017.