Coronary Artery DiseaseNCT02528474
Comparison of Optical Coherence Tomographic Findings After Balloon Angioplasty With Two Different Paclitaxel-Coated Balloons for the Treatment of In-Stent Restenosis in Drug-Eluting Stents
A study testing balloon angioplasty with Pantera Lux and balloon angioplasty with SeQuent Please in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Drug-coated balloon technology (DCB) has recently attracted considerable interest as a promising alternative treatment option, particularly in the setting of in-stent restenosis (ISR). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- balloon angioplasty with Pantera Lux and balloon angioplasty with SeQuent Please
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2015to 20 Apr 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 19 years old
- Patients eligible for percutaneous coronary intervention
- Single or more lesion(s) of restenosis requiring angioplasty in drug-eluting stent
- Reference vessel diameter of target lesion ≥2.5 mm
Who cannot join
- Cardiogenic shock
- Bifurcation lesion or totally occluded lesion
- Unprotected left main trunk lesion
- Allergies or hypersensitivities to antiplatelet, anticoagulation therapy, contrast media, or paclitaxel
- Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions
- Pregnant women or women with potential childbearing
- Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- Inability to understand or read the informed content
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
Drug-coated balloon technology (DCB) has recently attracted considerable interest as a promising alternative treatment option, particularly in the setting of in-stent restenosis (ISR). Optical coherence tomographic finding of restenosis lesions in drug-eluting stents (DESs) after Balloon Angioplasty with Two Different Paclitaxel-Coated Balloons will be compared between two paclitaxel-coated balloon devices; Pantera Lux™ and SeQuent® Please.
- Conditions
- Coronary Artery Disease
- Being tested
- balloon angioplasty with Pantera Lux, balloon angioplasty with SeQuent Please
- 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.
balloon angioplasty with Pantera LuxDevice
Patient will be considered to be enrolled if ISR in DES was found by angiography. After randomization, patients will be treated with Pantera Lux for treatment of ISR. OCT will be performed just after balloon angioplasty for ISR lesion. Information will be collected and recorded on the treated study vessel including angiographic and OCT parameters. Follow-up OCT at 9 month will be performed.
balloon angioplasty with SeQuent PleaseDevice
Patient will be considered to be enrolled if ISR in DES was found by angiography. After randomization, patients will be treated with SeQuent Please for treatment of ISR. OCT will be performed just after balloon angioplasty for ISR lesion. Information will be collected and recorded on the treated study vessel including angiographic and OCT parameters. Follow-up OCT at 9 month will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Pantera Lux | Experimental | Not described Receives: Device: balloon angioplasty with Pantera Lux |
| SeQuent Please | Active comparator | Not described Receives: Device: balloon angioplasty with SeQuent Please |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neointimal thickness & area
measured by OCT analysis
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 Aug 2015 (estimated)
- Study start30 Sep 2015
- Primary completion20 Apr 2017
- Study completion20 Apr 2017
Why it stopped: As it is difficult to recruit any more subjects, the investigators decided to terminate the study.
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 Yonsei UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528474
- Sponsor's protocol ID
- 1-2015-0041
- Status last verified
- Feb 2019
- First submitted
- 31 Jul 2015
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Optical Coherence Tomographic Findings After Balloon Angioplasty With Two Different Paclitaxel-Coated Balloons for the Treatment of In-Stent Restenosis in Drug-Eluting Stents
- ClinicalTrials.gov ID
- NCT02528474
- Acronym / sponsor ID
- 1-2015-0041
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As it is difficult to recruit any more subjects, the investigators decided to terminate the study.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 30 Sep 2015
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 19 Aug 2015 (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.
Drug-coated balloon technology (DCB) has recently attracted considerable interest as a promising alternative treatment option, particularly in the setting of in-stent restenosis (ISR). Optical coherence tomographic finding of restenosis lesions in drug-eluting stents (DESs) after Balloon Angioplasty with Two Different Paclitaxel-Coated Balloons will be compared between two paclitaxel-coated balloon devices; Pantera Lux™ and SeQuent® Please.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pantera Lux | Experimental | Device: balloon angioplasty with Pantera Lux |
| SeQuent Please | Active comparator | Device: balloon angioplasty with SeQuent Please |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 19 years old
- Patients eligible for percutaneous coronary intervention
- Single or more lesion(s) of restenosis requiring angioplasty in drug-eluting stent
- Reference vessel diameter of target lesion ≥2.5 mm
Key exclusion criteria (8 listed)
- Cardiogenic shock
- Bifurcation lesion or totally occluded lesion
- Unprotected left main trunk lesion
- Allergies or hypersensitivities to antiplatelet, anticoagulation therapy, contrast media, or paclitaxel
- Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions
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 |
|---|---|---|
| balloon angioplasty with Pantera LuxPatient will be considered to be enrolled if ISR in DES was found by angiography. After randomization, patients will be treated with Pantera Lux for treatment of ISR. OCT will be performed just after balloon angioplasty for ISR lesion. Information will be collected and recorded on the treated study vessel including angiographic and OCT parameters. Follow-up OCT at 9 month will be performed. | Device | Pantera Lux |
| balloon angioplasty with SeQuent PleasePatient will be considered to be enrolled if ISR in DES was found by angiography. After randomization, patients will be treated with SeQuent Please for treatment of ISR. OCT will be performed just after balloon angioplasty for ISR lesion. Information will be collected and recorded on the treated study vessel including angiographic and OCT parameters. Follow-up OCT at 9 month will be performed. | Device | SeQuent Please |
Primary outcome
Neointimal thickness & area
Time frame: 9 months
measured by OCT analysis
Results and safety
The study was stopped early (reason given: As it is difficult to recruit any more subjects, the investigators decided to terminate the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balloon angioplasty with Pantera Lux and balloon angioplasty with SeQuent Please in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
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 8 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: stopped early, as of the sponsor's last update on 29 Mar 2019. 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 South Korea. 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?
The study was stopped early (reason given: As it is difficult to recruit any more subjects, the investigators decided to terminate the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neointimal thickness & area (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 29 Mar 2019.