Coronary Artery DiseaseNCT04276389
OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery
A study testing OCT-guided paclitaxel drug-coated balloon angioplasty and Angiography-guided paclitaxel drug-coated balloon angioplasty in people with Coronary Artery Disease, run by Beijing Anzhen Hospital at 1 site 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 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- OCT-guided paclitaxel drug-coated balloon angioplasty and Angiography-guided paclitaxel drug-coated balloon angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 31 Aug 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 85 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, or silent ischemia.
- Reference vessel diameter >2.5 mm, and <4.0 mm.
- Lesion length of <22 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 or Killip≥3)
- Chronic kidney disease (eGFR <30 ml/min)
- Lesion length >22 mm, or vessel diameters of <2.5 mm or >4.0 mm
- Stents covering a major side branch (>2 mm)
- Left main lesion
Show all 13Show fewer
- Graft lesion
- Aortic-coronary ostial lesion
- In-stent restenotic lesion
- Chronic total occlusion
- Severe calcified lesions.
- Visible angiographic thrombus
- Severe comorbidities: eg. malignancy (life expectancy <2 years)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029
Yaping Zeng, MD, 86-10-84005255, zengyaping2@163.com
Xiao Wang, MD, 86-10-84005255, spaceeye123@126.com
About this study
Official title: OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery After Lesion Preparation With Scoring Balloon - A Prospective Multicenter Cohort Study
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 cohort study aims to assess the efficacy and safety of OCT- versus angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery after lesion preparation with scoring balloon.
- Conditions
- Coronary Artery Disease
- Being tested
- OCT-guided paclitaxel drug-coated balloon angioplasty, Angiography-guided paclitaxel drug-coated balloon angioplasty
- 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.
OCT-guided paclitaxel drug-coated balloon angioplastyDevice
OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
Angiography-guided paclitaxel drug-coated balloon angioplastyDevice
Angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
| Study group | Role | What they receive |
|---|---|---|
| OCT-guided arm | Active comparator | Not described Receives: Device: OCT-guided paclitaxel drug-coated balloon angioplasty |
| Angiography-guided arm | Placebo comparator | Not described Receives: Device: Angiography-guided paclitaxel drug-coated balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumen loss
Evaluated by QCA
Measured: 9 months
Secondary outcomes (2)
Rate of binary restenosis
Evaluated by QCA
Measured: 9 months
Target lesion failure
Including death, target vessel myocardial infarction, or target lesion revascularization
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Aug 2017
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shao-Ping Nie, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276389
- Sponsor's protocol ID
- 2018015
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- 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 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery After Lesion Preparation With Scoring Balloon - A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04276389
- Acronym / sponsor ID
- 2018015
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 19 Feb 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 cohort study aims to assess the efficacy and safety of OCT- versus angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery after lesion preparation with scoring balloon.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT-guided arm | Active comparator | Device: OCT-guided paclitaxel drug-coated balloon angioplasty |
| Angiography-guided arm | Placebo comparator | Device: Angiography-guided paclitaxel drug-coated balloon angioplasty |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 85 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, or silent ischemia.
- Reference vessel diameter >2.5 mm, and <4.0 mm.
- Lesion length of <22 mm
- Written informed consent
Key exclusion criteria (13 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 or Killip≥3)
- Chronic kidney disease (eGFR <30 ml/min)
- Lesion length >22 mm, or vessel diameters of <2.5 mm or >4.0 mm
- Stents covering a major side branch (>2 mm)
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 |
|---|---|---|
| OCT-guided paclitaxel drug-coated balloon angioplastyOCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery | Device | OCT-guided arm |
| Angiography-guided paclitaxel drug-coated balloon angioplastyAngiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery | Device | Angiography-guided arm |
Primary outcome
Late lumen loss
Time frame: 9 months
Evaluated by QCA
2 secondary outcomes
Rate of binary restenosis
Time frame: 9 months
Target lesion failure
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT-guided paclitaxel drug-coated balloon angioplasty and Angiography-guided paclitaxel drug-coated balloon angioplasty in people with Coronary Artery Disease, run by Beijing Anzhen 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 5 inclusion and 13 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 19 Feb 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. Some participants in this study may receive a placebo. 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 Shao-Ping Nie, MD, PhD (86-10-84005256, spnie@ccmu.edu.cn), 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). 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 19 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.