Coronary VesselsROTA-ISRNCT03401203
Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis
A study testing Rotational atherectomy followed by balloon angioplasty and Balloon angioplasty in people with Coronary Vessels, run by Seung-Jung Park at 3 sites in South Korea.
Trial summary
This study is to establish the primary hypothesis that debulking with rotational atherectomy (RA) followed by balloon angioplasty (BA) is superior to BA alone for lesion preparation in patients with coronary in-stent restenosis (ISR) regarding angiography-measured in-segment minimal lumen area at 1 year. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Vessels
- What is being tested?
- Rotational atherectomy followed by balloon angioplasty and Balloon angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 8 May 2018to 31 Dec 2022
- 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
- Men or women at least 19 years of age
- Subjects with coronary In-stent restenosis planned revascularization
- In-stent restenosis with neointimal hyperplasia evaluated by intravascular imaging
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- Complex lesion anatomy that disables rotational atherectomy
- Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- Life expectancy < 1 years for any non-cardiac or cardiac causes
- Unwillingness or inability to comply with the procedures described in this protocol.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Chonnam National University Hospital
Gwangju
Asan Medical Center
Seoul
About this study
Official title: A Prospective, Open Label, Multi-center, Dual Arm, Randomized Trial : The ROTA-ISR (Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis) Trial
This study is to establish the primary hypothesis that debulking with rotational atherectomy (RA) followed by balloon angioplasty (BA) is superior to BA alone for lesion preparation in patients with coronary in-stent restenosis (ISR) regarding angiography-measured in-segment minimal lumen area at 1 year.
- Conditions
- Coronary Vessels
- Being tested
- Rotational atherectomy followed by balloon angioplasty, Balloon angioplasty
- Keywords
- ISR, ROTA, DEB, PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational atherectomy followed by balloon angioplastyProcedure or surgery
Percutaneous coronary intervention
Balloon angioplastyProcedure or surgery
Percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| rotational atherectomy followed by balloon angioplasty | Experimental | Not described Receives: Procedure: Rotational atherectomy followed by balloon angioplasty |
| balloon angioplasty | Active comparator | Not described Receives: Procedure: Balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment minimal lumen diameter on angiographic
Measured: 1 year
Secondary outcomes (7)
Device success rate
Measured: 1 year
Angiographic outcomes immediate after procedure
In-segment and in-stent minimal lumen diameter and diameter stenosis
Measured: 1 hour
OCT outcomes immediate after procedure : In-segment and in-stent minimal lumen area
Measured: 1 hour
OCT outcomes immediate after procedure : In-segment and in-stent neointimal volume
Measured: 1 hour
Angiographic outcomes : In-segment and in-stent late loss, diameter stenosis
Measured: 1 year
OCT outcomes : in-segment and in-stent late lumen area, minimal lumen area loss
Measured: 1 year
composite event rate
A composite event of following factors is defined as the occurrence of any event from these events and denoted that event as the union of these.
- Death (cardiac, vascular, non-cardiovascular)
- Myocardial infarction (periprocedural, spontaneous)
- Stent thrombosis (definite/probable)
- Stroke
- Any revascularization
- Target lesion revascularization (TLR)
- Target vessel revascularization (TVR)
- Clinically significant bleeding (BARC type 2,3,4,5)
- Target lesion failure (cardiac death, target vessel MI or ischemia-driven TLR)
- Target vessel failure (cardiac death, target vessel MI or ischemia-driven TVR)
- A composite of all-cause death, MI, any repeat revascularization
- A composite of cardiac death, target vessel MI, stroke, or clinically significant bleeding (Bleeding Academic Research Consortium (BARC) type 2,3,4,5)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start8 May 2018
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary VesselsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401203
- Sponsor's protocol ID
- AMCCV2017-11
- Acronym
- ROTA-ISR
- Status last verified
- Jan 2023
- First submitted
- 25 Dec 2017
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Multi-center, Dual Arm, Randomized Trial : The ROTA-ISR (Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis) Trial
- ClinicalTrials.gov ID
- NCT03401203
- Acronym / sponsor ID
- ROTA-ISR / AMCCV2017-11
- Conditions
- Coronary Vessels
- Keywords
- ISR, ROTA, DEB, PCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 8 May 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Jan 2018 (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 is to establish the primary hypothesis that debulking with rotational atherectomy (RA) followed by balloon angioplasty (BA) is superior to BA alone for lesion preparation in patients with coronary in-stent restenosis (ISR) regarding angiography-measured in-segment minimal lumen area at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rotational atherectomy followed by balloon angioplasty | Experimental | Procedure: Rotational atherectomy followed by balloon angioplasty |
| balloon angioplasty | Active comparator | Procedure: Balloon angioplasty |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women at least 19 years of age
- Subjects with coronary In-stent restenosis planned revascularization
- In-stent restenosis with neointimal hyperplasia evaluated by intravascular imaging
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (4 listed)
- Complex lesion anatomy that disables rotational atherectomy
- Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- Life expectancy < 1 years for any non-cardiac or cardiac causes
- Unwillingness or inability to comply with the procedures described in this protocol.
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 |
|---|---|---|
| Rotational atherectomy followed by balloon angioplastyPercutaneous coronary intervention | Procedure or surgery | rotational atherectomy followed by balloon angioplasty |
| Balloon angioplastyPercutaneous coronary intervention | Procedure or surgery | balloon angioplasty |
Primary outcome
In-segment minimal lumen diameter on angiographic
Time frame: 1 year
7 secondary outcomes
Device success rate
Time frame: 1 year
Angiographic outcomes immediate after procedure
Time frame: 1 hour
OCT outcomes immediate after procedure : In-segment and in-stent minimal lumen area
Time frame: 1 hour
OCT outcomes immediate after procedure : In-segment and in-stent neointimal volume
Time frame: 1 hour
Angiographic outcomes : In-segment and in-stent late loss, diameter stenosis
Time frame: 1 year
OCT outcomes : in-segment and in-stent late lumen area, minimal lumen area loss
Time frame: 1 year
composite event rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotational atherectomy followed by balloon angioplasty and Balloon angioplasty in people with Coronary Vessels, run by Seung-Jung Park at 3 sites 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 4 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: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In-segment minimal lumen diameter on angiographic (time frame: 1 year). 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 4 Jan 2023.