Coronary Artery DiseaseCHART-PATTERNNCT04665466
Implication of Coronary Artery Disease Burden and Pattern in Ischemia-causing Vessels With PCI
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Ischemia-guided revascularization is the cornerstone of contemporary management of coronary artery disease (CAD). Coronary physiological assessment is advocated in the catheter laboratory to guide percutaneous coronary intervention (PCI), and it is widely accepted that an FFR ≤ 0.80 is a good indicator for vessels to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Atherosclerosis
- What is being tested?
- Quantitative Flow Ratio derived PPG
- Type of treatment
- Medical device
- How many people
- 1,003 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Feb 2021
- Phase
- Observational
- 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
Study population: 1003 patients with 1444 target vessels with measurable QFR≤ 0.80 from the PANDA-III study (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice) (NCT02017275).
Who may be able to join
- Patients with at least one vessel with measurable QFR≤ 0.80;
- PPG index can be calculated from virtual QFR pullback curve;
- The patient is willing to comply with specified follow-up evaluations;
- Patients who agree to accept the follow-up visits.
Who cannot join
- Culprit vessels for ACS myocardial infarction;
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
- Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
- Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated;
- Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
- Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined AngiograpHy-derived Fractional Flow Reserve and Pullback Pressure Gradient Assessment to Better Discriminate Coronary ARTery Disease PAtients Benefiting From PercuTaneous Coronary InTERventioN
Ischemia-guided revascularization is the cornerstone of contemporary management of coronary artery disease (CAD). Coronary physiological assessment is advocated in the catheter laboratory to guide percutaneous coronary intervention (PCI), and it is widely accepted that an FFR ≤ 0.80 is a good indicator for vessels to benefit from revascularization. Nevertheless, a significant proportion of PCI patients continue to experience adverse events related to both stented segment and/or residual or diffuse disease. Our group recently demonstrated the feasibility of pullback pressure gradient (PPG) derived from virtual Quantitative Flow Ratio (QFR) pullback curve, which is an index of atherosclerosis functional pattern and can be used to epitomize the pathophysiological pattern of CAD as focal or diffuse.
In this regard, the current study will investigate the incremental value of PPG added to QFR haemodynamic assessment in ischemia-causing vessels received PCI in predicting adverse outcomes.
Read the detailed description
Ischemia-guided revascularization is the cornerstone of contemporary management of coronary artery disease (CAD). Coronary physiological assessment is advocated in the catheter laboratory to guide percutaneous coronary intervention (PCI), and it is widely accepted that an FFR ≤ 0.80 is a good indicator for vessels to benefit from revascularization. Nevertheless, a significant proportion of PCI patients continue to experience adverse events related to both stented segment and/or residual or diffuse disease. Our group recently demonstrated the feasibility of pullback pressure gradient (PPG) derived from virtual Quantitative Flow Ratio (QFR) pullback curve, which is an index of atherosclerosis functional pattern and can be used to epitomize the pathophysiological pattern of CAD as focal or diffuse.
In this regard, the current study will investigate the incremental value of PPG added to QFR haemodynamic assessment in ischemia-causing vessels received PCI in predicting adverse outcomes.
The study cohort is derived from the PANDA-III study (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice) (NCT02017275). In this cohort, vessels with measurable QFR≤ 0.80 will be included. According to the PPG index calculated from QFR virtual pullback curve and treatment strategy chosen, the included vessels were divided into three groups(vessels with PCI strategy and low PPG index (group A), vessels with PCI strategy with high PPG index (group B) and vessels with conservative strategy (group C)) and 2-year clinical outcomes for each group will be compared.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Atherosclerosis, Percutaneous Coronary Intervention
- Being tested
- Quantitative Flow Ratio derived PPG
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Flow Ratio derived PPGDevice
From coronary angiographic images, QFR will be calculated and virtual pullback curve will be abstracted and PPG index will be calculated as:
PPG index={MaxPPG20mm/△QFRvessel+(1-length with functional disease/Total vessel length) }/2.
| Study group | Role | What they receive |
|---|---|---|
| Group A | QFR≤0.80 vessels with PCI strategy and low PPG index Receives: Device: Quantitative Flow Ratio derived PPG | |
| Group B | QFR≤0.80 vessels with PCI strategy and high PPG index Receives: Device: Quantitative Flow Ratio derived PPG | |
| Group C | QFR≤0.80 vessels with conservative strategy Receives: Device: Quantitative Flow Ratio derived PPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel-oriented composite outcome
Vessel-oriented composite outcome (VOCO) including vessel related ischemia-driven target vessel revascularization, vessel-related myocardial infarction (MI), and cardiac death.
Measured: at 2 years from index procedure
Secondary outcomes (3)
Cardiac death or vessel-related MI
Cardiac death or vessel-related MI
Measured: at 2 years from index procedure
Vessel-related MI
Vessel-related MI
Measured: at 2 years from index procedure
Cardiac death
Cardiac death
Measured: at 2 years from index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study startNov 2013
- Primary completionFeb 2021
- Study completionFeb 2021
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 Shanghai Zhongshan 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China National Center for Cardiovascular Diseases
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, Professor, Study chair, Fudan UniversityBo Xu, MBBS, Principal investigator, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665466
- Sponsor's protocol ID
- ZS-20201206
- Acronym
- CHART-PATTERN
- Status last verified
- Mar 2021
- First submitted
- 6 Dec 2020
- Last updated
- 2 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu B, Gao R, Yang Y, Cao X, Qin L, Li Y, Li Z, Li X, Lin H, Guo Y, Ma Y, Wang J, Nie S, Xu L, Cao E, Guan C, Stone GW; PANDA III Investigators. Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial. J Am Coll Cardiol. 2016 May 17;67(19):2249-2258. doi: 10.1016/j.jacc.2016.03.475.
PubMed 27173037
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined AngiograpHy-derived Fractional Flow Reserve and Pullback Pressure Gradient Assessment to Better Discriminate Coronary ARTery Disease PAtients Benefiting From PercuTaneous Coronary InTERventioN
- ClinicalTrials.gov ID
- NCT04665466
- Acronym / sponsor ID
- CHART-PATTERN / ZS-20201206
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Atherosclerosis, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- China National Center for Cardiovascular Diseases
- Study start
- Nov 2013 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 11 Dec 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.
Ischemia-guided revascularization is the cornerstone of contemporary management of coronary artery disease (CAD). Coronary physiological assessment is advocated in the catheter laboratory to guide percutaneous coronary intervention (PCI), and it is widely accepted that an FFR ≤ 0.80 is a good indicator for vessels to benefit from revascularization. Nevertheless, a significant proportion of PCI patients continue to experience adverse events related to both stented segment and/or residual or diffuse disease. Our group recently demonstrated the feasibility of pullback pressure gradient (PPG) derived from virtual Quantitative Flow Ratio (QFR) pullback curve, which is an index of atherosclerosis functional pattern and can be used to epitomize the pathophysiological pattern of CAD as focal or diffuse.
In this regard, the current study will investigate the incremental value of PPG added to QFR haemodynamic assessment in ischemia-causing vessels received PCI in predicting adverse outcomes.
Detailed description
Ischemia-guided revascularization is the cornerstone of contemporary management of coronary artery disease (CAD). Coronary physiological assessment is advocated in the catheter laboratory to guide percutaneous coronary intervention (PCI), and it is widely accepted that an FFR ≤ 0.80 is a good indicator for vessels to benefit from revascularization. Nevertheless, a significant proportion of PCI patients continue to experience adverse events related to both stented segment and/or residual or diffuse disease. Our group recently demonstrated the feasibility of pullback pressure gradient (PPG) derived from virtual Quantitative Flow Ratio (QFR) pullback curve, which is an index of atherosclerosis functional pattern and can be used to epitomize the pathophysiological pattern of CAD as focal or diffuse.
In this regard, the current study will investigate the incremental value of PPG added to QFR haemodynamic assessment in ischemia-causing vessels received PCI in predicting adverse outcomes.
The study cohort is derived from the PANDA-III study (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice) (NCT02017275). In this cohort, vessels with measurable QFR≤ 0.80 will be included. According to the PPG index calculated from QFR virtual pullback curve and treatment strategy chosen, the included vessels were divided into three groups(vessels with PCI strategy and low PPG index (group A), vessels with PCI strategy with high PPG index (group B) and vessels with conservative strategy (group C)) and 2-year clinical outcomes for each group will be compared.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: Quantitative Flow Ratio derived PPGQFR≤0.80 vessels with PCI strategy and low PPG index |
| Group B | – | Device: Quantitative Flow Ratio derived PPGQFR≤0.80 vessels with PCI strategy and high PPG index |
| Group C | – | Device: Quantitative Flow Ratio derived PPGQFR≤0.80 vessels with conservative strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1003 patients with 1444 target vessels with measurable QFR≤ 0.80 from the PANDA-III study (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice) (NCT02017275).
Key inclusion criteria (4 listed)
- Patients with at least one vessel with measurable QFR≤ 0.80;
- PPG index can be calculated from virtual QFR pullback curve;
- The patient is willing to comply with specified follow-up evaluations;
- Patients who agree to accept the follow-up visits.
Key exclusion criteria (6 listed)
- Culprit vessels for ACS myocardial infarction;
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
- Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
- Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated;
- Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
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 |
|---|---|---|
| Quantitative Flow Ratio derived PPGFrom coronary angiographic images, QFR will be calculated and virtual pullback curve will be abstracted and PPG index will be calculated as: PPG index={MaxPPG20mm/△QFRvessel+(1-length with functional disease/Total vessel length) }/2. | Device | Group A, Group B, Group C |
Primary outcome
Vessel-oriented composite outcome
Time frame: at 2 years from index procedure
Vessel-oriented composite outcome (VOCO) including vessel related ischemia-driven target vessel revascularization, vessel-related myocardial infarction (MI), and cardiac death.
3 secondary outcomes
Cardiac death or vessel-related MI
Time frame: at 2 years from index procedure
Vessel-related MI
Time frame: at 2 years from index procedure
Cardiac death
Time frame: at 2 years from index procedure
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 2 Apr 2021.
- Background: PubMed 27173037Xu B, Gao R, Yang Y, Cao X, Qin L, Li Y, Li Z, Li X, Lin H, Guo Y, Ma Y, Wang J, Nie S, Xu L, Cao E, Guan C, Stone GW; PANDA III Investigators. Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial. J Am Coll Cardiol. 2016 May 17;67(19):2249-2258. doi: 10.1016/j.jacc.2016.03.475.
- 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.
Junbo Ge, Professor study chair
Fudan University
Bo Xu, MBBS principal investigator
Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Shanghai Zhongshan 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 4 inclusion and 6 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 2 Apr 2021. 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?
Vessel-oriented composite outcome (time frame: at 2 years from index procedure). 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 NCT04665466, 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 2 Apr 2021.