Coronary Artery DiseaseULTIMATE-IIINCT04255043
Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon
A study testing IVUS guidance and Angiography guidance in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk. Intravascular ultrasound (IVUS) can provide more details of coronary anatomy and stent implantation, overcoming a number of limitations of coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- IVUS guidance and Angiography guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2020to 30 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- De novo lesions, suitable for DCB treatment.
- Patients with high bleeding risk.
Who cannot join
- Target lesion length > 15mm.
- Severe calcified lesions.
- Left main disease.
- Ostial lesions.
- Three-vessel disease.
- Acute myocardial infarction within 48 hours.
- Target vessel received stent implantation.
- Hemodynamic instability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for Denovo Lesions in High Bleeding Risk Patients: a Prospective, Multi-center, Randomized Controlled Trial
Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk. Intravascular ultrasound (IVUS) can provide more details of coronary anatomy and stent implantation, overcoming a number of limitations of coronary angiography. However, the benefit of IVUS-guided DCB treatment has not been investigated. This study is designed to compare IVUS-guided and Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.
Read the detailed description
This is a prospective, multicenter, randomized controlled trial that aims to enroll 260 patients with high bleeding risk.
All patients with coronary denovo lesions suitable for DCB treatment will undergo 1:1 randomization to either IVUS guidance or Angiography guidance using the Central Randomization System.
All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol. Data and images will be collected during the index procedure, and at the predefined 7-month coronary angiography follow-up visit.
- Conditions
- Coronary Artery Disease
- Being tested
- IVUS guidance, Angiography guidance
- 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.
IVUS guidanceDevice
IVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment
Angiography guidanceDevice
DCB (Sequent® Please) treatment
| Study group | Role | What they receive |
|---|---|---|
| IVUS-guided DCB | Experimental | In the IVUS guidance group, IVUS assessment will be used before procedure, post-procedure, and at the follow-up. Receives: Device: IVUS guidance |
| Angiography-guided DCB | Active comparator | In the Angiography guidance group, DCB treatment will be guided by routine coronary angiography. Receives: Device: Angiography guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
late lumen loss (LLL) at 7 months after procedure
LLL is defined as the difference between postprocedural minimal lumen diameter (MLD) minus MLD at the time of angiographic follow-up
Measured: 7 months
Secondary outcomes (2)
Target vessel failure (TVF) at 6 months
TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target-vessel revascularization.
Measured: 6 months
bleeding at 6 months
bleeding
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start3 Feb 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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
- Model description
- All subjects will undergo 1:1 randomization to either IVUS or Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjie Zhang, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shao-Liang Chen, MD, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255043
- Sponsor's protocol ID
- KY20200110-02
- Acronym
- ULTIMATE-III
- Status last verified
- Nov 2024
- First submitted
- 20 Jan 2020
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao XF, Ge Z, Kong XQ, Chen X, Han L, Qian XS, Zuo GF, Wang ZM, Wang J, Song JX, Lin L, Pan T, Ye F, Wang Y, Zhang JJ, Chen SL; ULTIMATE Ⅲ Investigators. Intravascular Ultrasound vs Angiography-Guided Drug-Coated Balloon Angioplasty: The ULTIMATE Ⅲ Trial. JACC Cardiovasc Interv. 2024 Jul 8;17(13):1519-1528. doi: 10.1016/j.jcin.2024.04.014. Epub 2024 Jun 5.
PubMed 38842991
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for Denovo Lesions in High Bleeding Risk Patients: a Prospective, Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04255043
- Acronym / sponsor ID
- ULTIMATE-III / KY20200110-02
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 5 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.
Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk. Intravascular ultrasound (IVUS) can provide more details of coronary anatomy and stent implantation, overcoming a number of limitations of coronary angiography. However, the benefit of IVUS-guided DCB treatment has not been investigated. This study is designed to compare IVUS-guided and Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.
Detailed description
This is a prospective, multicenter, randomized controlled trial that aims to enroll 260 patients with high bleeding risk.
All patients with coronary denovo lesions suitable for DCB treatment will undergo 1:1 randomization to either IVUS guidance or Angiography guidance using the Central Randomization System.
All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol. Data and images will be collected during the index procedure, and at the predefined 7-month coronary angiography follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All subjects will undergo 1:1 randomization to either IVUS or Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.
| Arm | Type | Receives |
|---|---|---|
| IVUS-guided DCB | Experimental | Device: IVUS guidanceIn the IVUS guidance group, IVUS assessment will be used before procedure, post-procedure, and at the follow-up. |
| Angiography-guided DCB | Active comparator | Device: Angiography guidanceIn the Angiography guidance group, DCB treatment will be guided by routine coronary angiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- De novo lesions, suitable for DCB treatment.
- Patients with high bleeding risk.
Key exclusion criteria (8 listed)
- Target lesion length > 15mm.
- Severe calcified lesions.
- Left main disease.
- Ostial lesions.
- Three-vessel disease.
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 |
|---|---|---|
| IVUS guidanceIVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment | Device | IVUS-guided DCB |
| Angiography guidanceDCB (Sequent® Please) treatment | Device | Angiography-guided DCB |
Primary outcome
late lumen loss (LLL) at 7 months after procedure
Time frame: 7 months
LLL is defined as the difference between postprocedural minimal lumen diameter (MLD) minus MLD at the time of angiographic follow-up
2 secondary outcomes
Target vessel failure (TVF) at 6 months
Time frame: 6 months
bleeding at 6 months
Time frame: 6 months
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 15 Nov 2024.
- Derived from this study: PubMed 38842991Gao XF, Ge Z, Kong XQ, Chen X, Han L, Qian XS, Zuo GF, Wang ZM, Wang J, Song JX, Lin L, Pan T, Ye F, Wang Y, Zhang JJ, Chen SL; ULTIMATE Ⅲ Investigators. Intravascular Ultrasound vs Angiography-Guided Drug-Coated Balloon Angioplasty: The ULTIMATE Ⅲ Trial. JACC Cardiovasc Interv. 2024 Jul 8;17(13):1519-1528. doi: 10.1016/j.jcin.2024.04.014. Epub 2024 Jun 5.
- Individual participant dataSharing planned: No
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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.
Shao-Liang Chen, MD study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS guidance and Angiography guidance in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical 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 2 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: finished, as of the sponsor's last update on 15 Nov 2024. 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?
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?
late lumen loss (LLL) at 7 months after procedure (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04255043, which also lists 1 linked publication.
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 15 Nov 2024.