Coronary Artery DiseaseIVUS-CKDNCT06567938
Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease
A study testing Percutaneous coronary intervention in people with Coronary Artery Disease and Chronic Kidney Diseases, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The IVUS-CKD study is a prospective, randomized controlled, multicenter trial to determine whether the intravascular ultrasound (IVUS)-guided percutaneous coronary intervention is superior to the angiography-guidance in chronic kidney disease (CKD) patients with respect to target vessel failure (TVF) at 12 months… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Chronic Kidney Diseases
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,528 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- CKD patients with eGFR<60 mL/min/1.73 m^2
- De novo coronary lesion suitable for second-generation metallic drug-eluting stent placement and IVUS imaging
- Signed written informed consent
Who cannot join
- Onset of STEMI within 24 hours or emergent angiography
- Pregnant or childbearing women
- Co-morbidity with an estimated life expectancy of < 1 year
- LVEF ≤ 30%
- Cardiogenic shock or hemodynamic instability
- Severe hepatic dysfunction, defined as ALT or AST more than 5 times the ULN
Show all 21Show fewer
- PCI within the previous 12 months
- Target lesion of stent thrombosis or in-stent restenosis
- Any planned non-cardiac surgery within 12 months
- Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk
- Current enrolment in other clinical trials
- Contraindication to anti-platelet agents
- History of intracranial or gastrointestinal bleeding requiring transfusion or surgical intervention for control (excluding hemorrhoid)
- Chronic total occlusion lesion with unsuccessful guidewire crossing
- Current intake of nephrotoxic medications (e.g., nonsteroidal anti-inflammatory drugs except acetylsalicylic acid, phenylbutazone, aminoglycosides, amphotericin B, polymyxin, platinum complexes)
- Immune-related kidney disease or on hormone therapy (e.g. lupus nephritis, IgA nephropathy)
- Planned exposure to contrast within 72 h after the procedure, intravascular administration of contrast within the previous 5 days
- Intake of anticoagulants
- Hemoglobin <60 g/L
- Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
- Patients allergic to metals or contrast
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hopital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Ning Guo, PhD,MD, +86 13991229101, nguomd@mail.xjtu.edu.cn
Xin Huang, PhD,MD, +86 13571961135, hearthx@126.com
About this study
Official title: Intravascular Ultrasound-Guided or Angiography-Guided Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease: The IVUS-CKD Trial
The IVUS-CKD study is a prospective, randomized controlled, multicenter trial to determine whether the intravascular ultrasound (IVUS)-guided percutaneous coronary intervention is superior to the angiography-guidance in chronic kidney disease (CKD) patients with respect to target vessel failure (TVF) at 12 months after randomization.
- Conditions
- Coronary Artery Disease, Chronic Kidney Diseases
- Being tested
- Percutaneous coronary intervention
- Keywords
- Coronary Artery Disease, Chronic Kidney Disease, Percutaneous Coronary Intervention, Intravascular Ultrasound, Randomized Trial
- Medical subject headings
- Coronary Artery Disease, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Also called PCI
PCI with DES implantation
| Study group | Role | What they receive |
|---|---|---|
| IVUS-guidance PCI | Experimental | In the IVUS-guidance group, the optimal stent deployment criteria for non-left main lesion will include the following: : (1) the minimal lumen area (MLA) in the stented segment > 5.0 mm^2 or > 90% of the MLA at the distal reference segments, (2) plaque burden 5 mm proximal or distal to the stent edge is < 55%, and (3) absence of medial dissection over 3 mm in length. In the setting of a two-stent approach for distal left main bifurcation lesions, the optimal stent deployment criteria are an absolute minimal stent area (MSA) greater than 8 mm^2 for the left main, greater than 7 mm^2 for carina, greater than 6 mm^2 for the ostial or proximal left anterior descending artery, and greater than 5 mm^2 for the ostial or proximal left circumflex artery. For left main lesion treated with single-stent technique, the criteria are greater than 7mm^2 for distal and greater than 8mm^2 for proximal. Further treatment will be required if the criteria are not met. Receives: Procedure: Percutaneous coronary intervention |
| Angiography-guidance PCI | Active comparator | Angiographic success is defined as thrombolysis in myocardial infarction (TIMI) flow grade 3, and residual stenosis < 20%. Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR)
The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography-guidance groups.
Measured: 12 months
Secondary outcomes (10)
Hierarchical composite of target vessel failure
Hierarchical composite of cardiac death, target vessel MI, or clinically driven target vessel revascularization after randomization analyzed by win ratio method.
Measured: 12 months
30-day cardiorenal endpoint
A composite of contrast-associated acute kidney injury (CA-AKI), requiring specific treatment for acute renal failure, persistent decline in eGFR, MI, or all-cause death.
Measured: 30 days
Target vessel failure excluding periprocedural MI
The difference will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups.
Measured: 12 months
Cardiac death
Death that could not be attributed to a noncardiac etiology is considered cardiac death.
Measured: 12 months
Target vessel MI
Measured: 12 months
Clinically driven target vessel revascularization
Any clinically driven repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
Measured: 12 months
Spontaneous MI
Measured: 12 months
Target lesion failure
A composite of cardiac death, target vessel related MI, or clinically driven target lesion revascularization.
Measured: 12 months
Clinically driven target lesion revascularization
Measured: 12 months
Major adverse cardiovascular event
A composite of cardiac death, MI, definite stent thrombosis (ST), or clinically driven TVR
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start25 Jul 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (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 First Affiliated Hospital Xi'an Jiaotong 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,528 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Guo, Principal investigator, The First Affiliated of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567938
- Sponsor's protocol ID
- HXIIT2024007
- Acronym
- IVUS-CKD
- Status last verified
- Jun 2024
- First submitted
- 10 Jul 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound-Guided or Angiography-Guided Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease: The IVUS-CKD Trial
- ClinicalTrials.gov ID
- NCT06567938
- Acronym / sponsor ID
- IVUS-CKD / HXIIT2024007
- Conditions
- Coronary Artery Disease, Chronic Kidney Diseases
- Keywords
- Coronary Artery Disease, Chronic Kidney Disease, Percutaneous Coronary Intervention, Intravascular Ultrasound, Randomized Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,528 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Aug 2024 (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.
The IVUS-CKD study is a prospective, randomized controlled, multicenter trial to determine whether the intravascular ultrasound (IVUS)-guided percutaneous coronary intervention is superior to the angiography-guidance in chronic kidney disease (CKD) patients with respect to target vessel failure (TVF) at 12 months after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVUS-guidance PCI | Experimental | Procedure: Percutaneous coronary interventionIn the IVUS-guidance group, the optimal stent deployment criteria for non-left main lesion will include the following: : (1) the minimal lumen area (MLA) in the stented segment > 5.0 mm^2 or > 90% of the MLA at the distal reference segments, (2) plaque burden 5 mm proximal or distal to the stent edge is < 55%, and (3) absence of medial dissection over 3 mm in length. In the setting of a two-stent approach for distal left main bifurcation lesions, the optimal stent deployment criteria are an absolute minimal stent area (MSA) greater than 8 mm^2 for the left main, greater than 7 mm^2 for carina, greater than 6 mm^2 for the ostial or proximal left anterior descending artery, and greater than 5 mm^2 for the ostial or proximal left circumflex artery. For left main lesion treated with single-stent technique, the criteria are greater than 7mm^2 for distal and greater than 8mm^2 for proximal. Further treatment will be required if the criteria are not met. |
| Angiography-guidance PCI | Active comparator | Procedure: Percutaneous coronary interventionAngiographic success is defined as thrombolysis in myocardial infarction (TIMI) flow grade 3, and residual stenosis < 20%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CKD patients with eGFR<60 mL/min/1.73 m^2
- De novo coronary lesion suitable for second-generation metallic drug-eluting stent placement and IVUS imaging
- Signed written informed consent
Key exclusion criteria (21 listed)
- Onset of STEMI within 24 hours or emergent angiography
- Pregnant or childbearing women
- Co-morbidity with an estimated life expectancy of < 1 year
- LVEF ≤ 30%
- Cardiogenic shock or hemodynamic instability
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 |
|---|---|---|
| Percutaneous coronary interventionAlso: PCIPCI with DES implantation | Procedure or surgery | Angiography-guidance PCI, IVUS-guidance PCI |
Primary outcome
Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR)
Time frame: 12 months
The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography-guidance groups.
10 secondary outcomes
Hierarchical composite of target vessel failure
Time frame: 12 months
30-day cardiorenal endpoint
Time frame: 30 days
Target vessel failure excluding periprocedural MI
Time frame: 12 months
Cardiac death
Time frame: 12 months
Target vessel MI
Time frame: 12 months
Clinically driven target vessel revascularization
Time frame: 12 months
Spontaneous MI
Time frame: 12 months
Target lesion failure
Time frame: 12 months
Clinically driven target lesion revascularization
Time frame: 12 months
Major adverse cardiovascular event
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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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.
Ning Guo principal investigator
The First Affiliated of Xi'an Jiaotong 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 Percutaneous coronary intervention in people with Coronary Artery Disease and Chronic Kidney Diseases, run by First Affiliated Hospital Xi'an Jiaotong 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 3 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 23 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Guo, PhD,MD (+86 13991229101, nguomd@mail.xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) (time frame: 12 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 23 Aug 2024.