AngioplastyPEBCBLONCT02276846
Palpitate-Eluting Balloon Angioplasty in the Treatment of Coronary Bifurcation Lesion Evaluated by OCT
An observational study of Angioplasty and Percutaneous Coronary Intervention, run by Second Hospital of Jilin University at 1 site in China.
Trial summary
The aim of the study is to use optical coherence tomography (OCT) to investigate the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) in SB and drug eluting stent (EXCEL stent) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 4.0 mm, reference diameter of side branch: ≥ 2.0 mm and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Angioplasty, Percutaneous Coronary Intervention
- What is being tested?
- Paclitaxel-Eluting Balloon
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2015
- How long will I take part?
- 9 Months
- Phase
- Observational
- 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
Study population: This study is designed for 25 subsequent patients with coronary heart disease to complete the study per protocol. Eligible patients shall exhibit a bifurcational lesion in the native left coronary artery (reference diameter LAD or LCx: 2.5 mm -4.0 mm, length of stenosis: ≤30 mm, reference diameter D1/D2 or OMS1/OMS2: 2.0 mm-3.5 mm, length of stenosis: ≤ 30 mm) in need of percutaneous coronary intervention. Eligible patients may have single or multivessel coronary artery disease.
Who may be able to join
- Patient Inclusion Criteria
- Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
- Patients eligible for coronary revascularization by means of PCI
- Patients must be 18 years of age
- Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 6-month follow-up
- Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
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- Patients must agree to undergo the 9-month angiographic follow-up
- Patients must agree to undergo the 3-year clinical follow-up
- Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives of this trial. The patients, by providing their informed consent, must agree to these risks and benefits as stated in the patient informed consent document.
- De-novo bifurcational native left coronary artery lesion (reference diameter LAD or LCx:2.5 mm-4.0 mm, length of stenosis: ≤30 mm, reference diameter D1/D2 or OMS1/OMS2:2.0 mm -3.5 mm, length of stenosis: ≤30 mm)
- Diameter stenosis pre procedure must be either 70 % in either one or both branches of the lesion (i.e. bifurcational lesion of any type of the Medina classification) or 50 % if ischemia corresponding to the target lesion is documented either by exercise stress ECG, stress echocardiography, scintigraphy, MRT, or suspected based on angina pectoris
- Single or multi-vessel coronary artery disease
Who cannot join
- Patient Exclusion Criteria
- Patients with acute (<24 h) or recent (48 hours) myocardial infarction
- Patients with unstable angina pectoris (Braunwald class 3)
- Patients with severe congestive heart failure
- Patients with severe heart failure NYHA IV
- Patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mmHg requiring inotropic support, IABP, and/or fluid challenge)
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- Patients with severe valvular heart disease
- Women who are pregnant or lactating
- Patients with life expectancy of less than five years or factors making clinical follow-up difficult
- Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
- Patients who had a cerebral stroke <6 months prior to the procedure
- Patient participates in other clinical trials involving any investigational device or drug
- Untreated hyperthyroidism
- Patient has presence or history of severe renal failure (GFR<30ml/min, "Cockcroft Gault") and is therefore at high risk for angiography associated renal complications. Patient's serum creatinine levels must be documented
- Post transplantation of any organ or immune suppressive medication
- Other disease to jeopardize follow-up (e.g,malignancy)
- Addiction to any drug or to alcohol
- Patients with any type of surgery during the week preceding the interventional procedure.
- Therapy with anticoagulants
- After PTCA,Coronary artery dissection appears Exclusion Criteria: Lesion Related
- Evidence of extensive thrombosis within target vessel before the intervention
- Multilesion percutaneous coronary intervention beside the bifurcation lesion in the left coronary artery (no other intervention is admitted during the same procedure)
- Patients with another coronary stent implanted previously into the target vessel ≤15 mm distant to the current lesion, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEBCBLO
- Target lesion located in any type of coronary bypass (i.e,venous graft, arterial bypass) or graft/native artery connection
- Coronary artery occlusion of any type (e.g, acute or chronic)
- In-stent restenosis
- In-segment restenosis of the native vessel within 4 mm adjacent to the target lesion Exclusion Criteria Related to Concomitant Medication
- Patient is intolerant to aspirin and/or the ADP-antagonists clopidogrel/ticlopidine or has a history of neutropenia, thrombocytopenia induced by ADP-antagonists, or severe hepatic dysfunction prohibiting the use of clopidogrel
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130041
Liu Bin, M.D., +86 13500810268, liubin3333@vip.sina.com
About this study
The aim of the study is to use optical coherence tomography (OCT) to investigate the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) in SB and drug eluting stent (EXCEL stent) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 4.0 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 30 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native coronary artery as reflected by procedural success and to evaluate the preservation of vessel patency.
Read the detailed description
Catheter interventions of coronary lesions involve a bifurcation in 15-20%. The treatment of bifurcation lesions is usually more difficult as compared to non-bifurcation lesions and the complication rate is higher. Possible complications are acute SB closure (BBC one) and higher rates of restenosis and stent thrombosis. Carina shifting after stenting ,double or triple layers of stents, stent distortion and different tissue distribution may be the reasons. The use of drug-eluding stents in the treatment of bifurcation lesions suggests that DES reduces the rate of restenosis int he main branch (5-10%); however, results in the side branch are not optimal. Current interventional treatment of most bifurcation lesions consists in implanting a DES in the MB with POBA and provisional T-stenting of the SB. Drug eluting Balloon is the new options and improvements in the field of coronary angioplasty. Clinically proven, it offers completely new procedural options to treat vascular stenoses since the drug elution does not require a stent platform. Since the SB is rarely stented, the DEB could be particularly helpful to reduce the restenosis rate of a SB lesion. PEPCAD V trial has proved Percutaneous treatment of bifurcation lesions with a drug-eluting balloon resulted in a procedural success of 100%. Follow-up angiography at nine months showed DES-like results in MB and SB. In PEPCAD V trial，the MB was dilated with a DEB. Next, a BMS (CoroflexR, B. Braun Melsungen AG, Germany) was implanted in the MB. While the procedure is complex, whether we can put drug eluting stent in MB directly and this overlap of drug delivery is harmful. OCT system had an axial resolution of 20 microm and a transverse resolution of 30 microm. OCT was able to penetrate and image near-occlusive coronary plaques. Therefore, it is prudent to use OCT to investigate the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) in SB and drug eluting stent (EXCEL stent) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 4.0 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 30 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native coronary artery as reflected by procedural success and to evaluate the preservation of vessel patency.
- Conditions
- Angioplasty, Percutaneous Coronary Intervention
- Being tested
- Paclitaxel-Eluting Balloon
- Keywords
- Palpitate-Eluting Balloon, Bifurcation, OCT, Transluminal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-Eluting BalloonDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment late lumen loss
In-segment late lumen loss in the side branch and main branch evaluated by OCT
Measured: 9 months
Secondary outcomes (2)
major adverse cardiac events (MACE)
cardiac death, myocardial infarction and target lesion revascularization
Measured: 9 months
Procedural success
a stenosis ≤30% in the MB and ≤50% in the SB along with TIMI III flow
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Second Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Bin, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276846
- Sponsor's protocol ID
- SecondJilinU
- Acronym
- PEBCBLO
- Status last verified
- Oct 2014
- First submitted
- 12 Oct 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palpitate-Eluting Balloon Angioplasty in the Treatment of Coronary Bifurcation Lesion Evaluated by OCT
- ClinicalTrials.gov ID
- NCT02276846
- Acronym / sponsor ID
- PEBCBLO / SecondJilinU
- Conditions
- Angioplasty, Percutaneous Coronary Intervention
- Keywords
- Palpitate-Eluting Balloon, Bifurcation, OCT, Transluminal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 28 Oct 2014 (estimated)
- 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 aim of the study is to use optical coherence tomography (OCT) to investigate the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) in SB and drug eluting stent (EXCEL stent) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 4.0 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 30 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native coronary artery as reflected by procedural success and to evaluate the preservation of vessel patency.
Detailed description
Catheter interventions of coronary lesions involve a bifurcation in 15-20%. The treatment of bifurcation lesions is usually more difficult as compared to non-bifurcation lesions and the complication rate is higher. Possible complications are acute SB closure (BBC one) and higher rates of restenosis and stent thrombosis. Carina shifting after stenting ,double or triple layers of stents, stent distortion and different tissue distribution may be the reasons. The use of drug-eluding stents in the treatment of bifurcation lesions suggests that DES reduces the rate of restenosis int he main branch (5-10%); however, results in the side branch are not optimal. Current interventional treatment of most bifurcation lesions consists in implanting a DES in the MB with POBA and provisional T-stenting of the SB. Drug eluting Balloon is the new options and improvements in the field of coronary angioplasty. Clinically proven, it offers completely new procedural options to treat vascular stenoses since the drug elution does not require a stent platform. Since the SB is rarely stented, the DEB could be particularly helpful to reduce the restenosis rate of a SB lesion. PEPCAD V trial has proved Percutaneous treatment of bifurcation lesions with a drug-eluting balloon resulted in a procedural success of 100%. Follow-up angiography at nine months showed DES-like results in MB and SB. In PEPCAD V trial，the MB was dilated with a DEB. Next, a BMS (CoroflexR, B. Braun Melsungen AG, Germany) was implanted in the MB. While the procedure is complex, whether we can put drug eluting stent in MB directly and this overlap of drug delivery is harmful. OCT system had an axial resolution of 20 microm and a transverse resolution of 30 microm. OCT was able to penetrate and image near-occlusive coronary plaques. Therefore, it is prudent to use OCT to investigate the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) in SB and drug eluting stent (EXCEL stent) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 4.0 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 30 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native coronary artery as reflected by procedural success and to evaluate the preservation of vessel patency.
Study design
- Time perspective
- Prospective
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is designed for 25 subsequent patients with coronary heart disease to complete the study per protocol. Eligible patients shall exhibit a bifurcational lesion in the native left coronary artery (reference diameter LAD or LCx: 2.5 mm -4.0 mm, length of stenosis: ≤30 mm, reference diameter D1/D2 or OMS1/OMS2: 2.0 mm-3.5 mm, length of stenosis: ≤ 30 mm) in need of percutaneous coronary intervention. Eligible patients may have single or multivessel coronary artery disease.
Key inclusion criteria (12 listed)
- Patient Inclusion Criteria
- Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
- Patients eligible for coronary revascularization by means of PCI
- Patients must be 18 years of age
- Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 6-month follow-up
Key exclusion criteria (28 listed)
- Patient Exclusion Criteria
- Patients with acute (<24 h) or recent (48 hours) myocardial infarction
- Patients with unstable angina pectoris (Braunwald class 3)
- Patients with severe congestive heart failure
- Patients with severe heart failure NYHA IV
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-Eluting Balloon | Device | – |
Primary outcome
In-segment late lumen loss
Time frame: 9 months
In-segment late lumen loss in the side branch and main branch evaluated by OCT
2 secondary outcomes
major adverse cardiac events (MACE)
Time frame: 9 months
Procedural success
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angioplasty and Percutaneous Coronary Intervention, run by Second Hospital of Jilin University 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 12 inclusion and 28 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 28 Oct 2014. 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 Liu Bin, M.D. (+86 13500810268, liubin3333@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-segment late lumen loss (time frame: 9 months). 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 28 Oct 2014.