Coronary DiseaseL-SandwichNCT04753827
"L-Sandwich" Strategy in the True Coronary Bifurcation Lesions
A study testing Drug eluting stent and Durg coated balloon in people with Coronary Disease, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
The treatment of coronary bifurcation lesions continue to remain challenges. Due to the complexity of the anatomical structure and the limitations of imaging, there are poor attachment and under-expansion of the stent at the branch ostium, which causes in-stent thrombosis and restenosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Drug eluting stent and Durg coated balloon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 3 Oct 2021to 20 Jul 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with true bifurcation disease with SB lesion length>25mm
Who cannot join
- SB diameter<2.5mm
- presence of cardiogenic shock or cardiopulmonary resuscitation
- Expected survival <1 year
- Allergy to indexed medications
- Intolerable to dual antiplatelet therapy
- pregnant
- Severe calcification needing rotational atherectomy
Trial locations and contacts
1 site in 1 country.
About this study
The treatment of coronary bifurcation lesions continue to remain challenges. Due to the complexity of the anatomical structure and the limitations of imaging, there are poor attachment and under-expansion of the stent at the branch ostium, which causes in-stent thrombosis and restenosis. The delayed re-endothelialization arise from multi-layer stents. The one-stent strategy causes the displacement of the plaques and ridges of the branch ostium, and thus insufficient blood flow to the branches. The "L-sandwich" strategy, stents were implanted in the main vessel(MV) and the shaft of side branch(SB) respectively, then a drug-coated balloon(DCB) was applied to the ostium of the SB, to improve the tedious operation process in true bifurcation lesions and reduce postoperative complications. The purpose of this study was to explore the feasibility, safety, and efficacy of the "sandwich" strategy.
Read the detailed description
This is a study to evaluate the application of L-Sandwich in true bifurcation coronary artery disease.All eligible patients were randomly divided into three groups: experimental group 1: dual stent group: both main vessel(MV) and side branch(SB) were stented, and DK-Crush or Culotte were performed according to different pathological characteristics. Experimental group 2: single stent + drug-coated balloon（DCB）: stent was implanted in the MV, and only drug balloon was used in the SB.Experimental group 3: L-Sandwich : stent was implanted in the MV, and the branch was implanted 3-5mm away from the ostium，and the DCB was implanted in the ostium of the branch.IVUS+ angiography was used to guide the operation and evaluate the outcome.
- Conditions
- Coronary Disease
- Being tested
- Drug eluting stent, Durg coated balloon
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug eluting stentOther
Put a Drug eluting stent in the blood vessel
Durg coated balloonOther
Put a Durg coated balloon in the blood vessel
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group Stent only | Experimental | Stents were implanted in MV and SB respectively, and DKcrush or Culotte technology was selected according to the lesion characteristics. Receives: Other: Drug eluting stent |
| Experimental Group Stent+DCB | Experimental | The MV was stented and the SB were treated with just drug-coated balloon(DCB) Receives: Other: Drug eluting stent; Other: Durg coated balloon |
| Experimental Group L-Sandwich | Experimental | Stents were implanted in the MV and the shaft of side branch SB respectively, then a DCB was applied to the ostium of the SB Receives: Other: Drug eluting stent; Other: Durg coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
main vessel late lumen loss
main vessel late lumen loss
Measured: 6 months
Side branch late lumen loss
Side branch late lumen loss
Measured: 6 months
Secondary outcomes (2)
Target lesion failure rate
Cardiac death,Target vessel MI,Target lesion revascularization
Measured: 30days
Target lesion failure rate
Cardiac death,Target vessel MI,Target lesion revascularization
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 posted15 Feb 2021
- Study start3 Oct 2021
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three different strategies for true bifurcation
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muwei Li, MD, Study chair, FF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753827
- Sponsor's protocol ID
- HenanICE202102
- Acronym
- L-Sandwich
- Status last verified
- Aug 2022
- First submitted
- 10 Feb 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Others can obtain the individual participant data from the researcher by reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "L-Sandwich" Strategy in the True Coronary Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT04753827
- Acronym / sponsor ID
- L-Sandwich / HenanICE202102
- Conditions
- Coronary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 15 Feb 2021 (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 treatment of coronary bifurcation lesions continue to remain challenges. Due to the complexity of the anatomical structure and the limitations of imaging, there are poor attachment and under-expansion of the stent at the branch ostium, which causes in-stent thrombosis and restenosis. The delayed re-endothelialization arise from multi-layer stents. The one-stent strategy causes the displacement of the plaques and ridges of the branch ostium, and thus insufficient blood flow to the branches. The "L-sandwich" strategy, stents were implanted in the main vessel(MV) and the shaft of side branch(SB) respectively, then a drug-coated balloon(DCB) was applied to the ostium of the SB, to improve the tedious operation process in true bifurcation lesions and reduce postoperative complications. The purpose of this study was to explore the feasibility, safety, and efficacy of the "sandwich" strategy.
Detailed description
This is a study to evaluate the application of L-Sandwich in true bifurcation coronary artery disease.All eligible patients were randomly divided into three groups: experimental group 1: dual stent group: both main vessel(MV) and side branch(SB) were stented, and DK-Crush or Culotte were performed according to different pathological characteristics. Experimental group 2: single stent + drug-coated balloon（DCB）: stent was implanted in the MV, and only drug balloon was used in the SB.Experimental group 3: L-Sandwich : stent was implanted in the MV, and the branch was implanted 3-5mm away from the ostium，and the DCB was implanted in the ostium of the branch.IVUS+ angiography was used to guide the operation and evaluate the outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three different strategies for true bifurcation
| Arm | Type | Receives |
|---|---|---|
| Experimental Group Stent only | Experimental | Other: Drug eluting stentStents were implanted in MV and SB respectively, and DKcrush or Culotte technology was selected according to the lesion characteristics. |
| Experimental Group Stent+DCB | Experimental | Other: Drug eluting stent, Other: Durg coated balloonThe MV was stented and the SB were treated with just drug-coated balloon(DCB) |
| Experimental Group L-Sandwich | Experimental | Other: Drug eluting stent, Other: Durg coated balloonStents were implanted in the MV and the shaft of side branch SB respectively, then a DCB was applied to the ostium of the SB |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with true bifurcation disease with SB lesion length>25mm
Key exclusion criteria (7 listed)
- SB diameter<2.5mm
- presence of cardiogenic shock or cardiopulmonary resuscitation
- Expected survival <1 year
- Allergy to indexed medications
- Intolerable to dual antiplatelet therapy
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 |
|---|---|---|
| Drug eluting stentPut a Drug eluting stent in the blood vessel | Other | Experimental Group L-Sandwich, Experimental Group Stent only, Experimental Group Stent+DCB |
| Durg coated balloonPut a Durg coated balloon in the blood vessel | Other | Experimental Group L-Sandwich, Experimental Group Stent+DCB |
Primary outcome
main vessel late lumen loss
Time frame: 6 months
main vessel late lumen loss
Side branch late lumen loss
Time frame: 6 months
Side branch late lumen loss
2 secondary outcomes
Target lesion failure rate
Time frame: 30days
Target lesion failure rate
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 5 Aug 2022.
- Individual participant dataSharing planned: No. Others can obtain the individual participant data from the researcher by reasonable request
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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, MD study chair
FF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug eluting stent and Durg coated balloon in people with Coronary 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 1 inclusion and 7 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 5 Aug 2022. 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?
main vessel late lumen loss (time frame: 6 months). The study lists 2 primary outcomes in all. 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 5 Aug 2022.