Coronary Heart DiseasePSSCCENCT06168422
A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly
An observational study of Coronary Heart Disease, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
The aim of this observational study is to compare the prognostic outcomes of various PCI strategies in elderly patients with complex coronary calcified lesions. The patients will be classified into two groups and assigned different PCI strategies, either stenting or stenting combined with pharmacologic balloon… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- DES and DCB
- Type of treatment
- Medical device
- How many people
- 2,100 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2023to 6 May 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly patients with calcified coronary artery disease
Who may be able to join
- Age ≥ 60 years;
- Meet the indications for coronary intervention;
- IVUS examination suggests severe calcified lesions (calcification angle >270°) or OCT examination suggests severe calcified lesions (calcification angle >180° and/or length >5mm and/or thickness >0.5mm);
- The diameter of the target lesion vessel is greater than 2.75mm;
- The total length of the lesion is more than 60mm and/or the number of lesions to be treated is ≥3 and/or the number of vessels to be treated is ≥2.
Who cannot join
- inability to provide written informed consent;
- inability to administer antiplatelet agents and anticoagulant therapy;
- the subject is participating in other unfinished clinical trials;
- life expectancy <1 year;
- non-in situ vascular lesions;
- patients with haemodynamic instability;
- Previous stroke within 6 months.
- left main stem lesions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan
Quan Guo, xinyiguoquan@163.com
Muwei Li, phd
About this study
The aim of this observational study is to compare the prognostic outcomes of various PCI strategies in elderly patients with complex coronary calcified lesions. The patients will be classified into two groups and assigned different PCI strategies, either stenting or stenting combined with pharmacologic balloon implantation. The investigators will assess the one-year prognosis for major adverse cardiovascular events in these patients.
- Conditions
- Coronary Heart Disease
- Being tested
- DES, DCB
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESDevice
drug eluting stent
DCBDevice
drug-coated balloon
| Study group | Role | What they receive |
|---|---|---|
| DES Group | All lesions in these patients were treated with DES Receives: Device: DES | |
| DES+DCB Group | These patients were treated using a combination of DES and DCB Receives: Device: DES; Device: DCB | |
| DCB Group | All lesions in these patients were treated with DCB Receives: Device: DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACEs
A Composite Event Including Cardiac Death, Myocardial Infarction, Stroke, and Target Vessel Revascularization
Measured: 12 months
Secondary outcomes (5)
Cardiac Death
Cardiac Death
Measured: 12 months
Myocardial Infarction
Myocardial Infarction
Measured: 12 months
Target Vessel Revascularization
Target Vessel Revascularization
Measured: 12 months
Stroke
Stroke
Measured: 12 months
BRCA 2,3-5
BRCA 2,3-5
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 posted13 Dec 2023
- Study start25 Dec 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion6 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muwei Li, Principal investigator, Fuwai central China cardiovascular hospotial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168422
- Sponsor's protocol ID
- HenanICE202312
- Acronym
- PSSCCE
- Status last verified
- Jun 2024
- First submitted
- 5 Dec 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly
- ClinicalTrials.gov ID
- NCT06168422
- Acronym / sponsor ID
- PSSCCE / HenanICE202312
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 6 May 2025 (estimated)
- First posted
- 13 Dec 2023 (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 aim of this observational study is to compare the prognostic outcomes of various PCI strategies in elderly patients with complex coronary calcified lesions. The patients will be classified into two groups and assigned different PCI strategies, either stenting or stenting combined with pharmacologic balloon implantation. The investigators will assess the one-year prognosis for major adverse cardiovascular events in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DES Group | – | Device: DESAll lesions in these patients were treated with DES |
| DES+DCB Group | – | Device: DES, Device: DCBThese patients were treated using a combination of DES and DCB |
| DCB Group | – | Device: DCBAll lesions in these patients were treated with DCB |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients with calcified coronary artery disease
Key inclusion criteria (5 listed)
- Age ≥ 60 years;
- Meet the indications for coronary intervention;
- IVUS examination suggests severe calcified lesions (calcification angle >270°) or OCT examination suggests severe calcified lesions (calcification angle >180° and/or length >5mm and/or thickness >0.5mm);
- The diameter of the target lesion vessel is greater than 2.75mm;
- The total length of the lesion is more than 60mm and/or the number of lesions to be treated is ≥3 and/or the number of vessels to be treated is ≥2.
Key exclusion criteria (8 listed)
- inability to provide written informed consent;
- inability to administer antiplatelet agents and anticoagulant therapy;
- the subject is participating in other unfinished clinical trials;
- life expectancy <1 year;
- non-in situ vascular 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 |
|---|---|---|
| DESdrug eluting stent | Device | DES Group, DES+DCB Group |
| DCBdrug-coated balloon | Device | DCB Group, DES+DCB Group |
Primary outcome
MACEs
Time frame: 12 months
A Composite Event Including Cardiac Death, Myocardial Infarction, Stroke, and Target Vessel Revascularization
5 secondary outcomes
Cardiac Death
Time frame: 12 months
Myocardial Infarction
Time frame: 12 months
Target Vessel Revascularization
Time frame: 12 months
Stroke
Time frame: 12 months
BRCA 2,3-5
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Muwei Li principal investigator
Fuwai central China cardiovascular hospotial
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 Heart Disease, run by Henan Institute of Cardiovascular Epidemiology 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 5 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: status not confirmed, as of the sponsor's last update on 27 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quan Guo (+8615670510031, xinyiguoquan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACEs (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 27 Jun 2024.