Coronary Heart DiseaseNCT02768116
The Study of Active Transfer of Plaque Technique for Non-Left Main Coronary Bifurcation Lesions
A study testing Sirolimus Drug-eluting Stent via Active Transfer of Plaque and Sirolimus Drug-eluting Stent implantation via Provisional T Stenting in people with Coronary Heart Disease, run by Beijing Anzhen Hospital.
Trial summary
A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary Bifurcation Lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Sirolimus Drug-eluting Stent via Active Transfer of Plaque and Sirolimus Drug-eluting Stent implantation via Provisional T Stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2021
- 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
- Patient must be at least >18, ≤80 years of age.
- Patient has Stable/unstable angina or NSTEMI.
- Patient has STEMI>24-hour from the onset of chest pain to admission.
- Non-left-main coronary bifurcation lesion. (Medina 0,1,1;1,1,1;1,0,1;1,1,0).
- Patient is eligible for elective percutaneous coronary intervention (PCI) .
- Patient is an acceptable candidate for coronary artery bypass grafting (CABG).
- Patient (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; patient is willing to comply with all protocol-required follow-up evaluations.
Who cannot join
- Patient with STEMI (within 24-hour from the onset of chest pain to admission).
- Patient has known allergy to the study stent system or protocol-required concomitant medications that cannot be adequately pre-medicated (everolimus, aspirin, contrast media, acrylic acid, Stainless steel).
- Patient has intolerable to dual anti-platelet therapy.
- Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
- Patient is pregnant or nursing.
- Patient is participating in another clinical trial that has not reached its primary endpoint.
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- Patient with severe calcified lesions needing rotational atherectomy.
- Lesions of in-stent restenosis.
- Patients not eligible for this trial based on investigators' judgement.
About this study
Official title: A Prospective Multicenter Randomized Trial Comparing Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary Bifurcation Lesions
A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary Bifurcation Lesions.
Read the detailed description
A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary Bifurcation Lesions.
The purpose of this trial is to evaluate the efficacy and safety of Active Transfer of Plaque and provisional T stenting techniques treating non-left-main coronary bifurcation lesions based on TLR rate 12-months post-procedure.
Provisional T Stenting is a common technique in BL treatment. Active Transfer of Plaque or ATP was reported, but there are no comparison between two procedure. In the ATP treatment of bifurcation lesions, two wires are advanced to distal main vessel (MV) and side branch(SB). Stent and balloon are advanced to MV and SB respectively. The MV stent is released while dilating the SB balloon. By predilating the balloon in the target SB, the plaque will be actively transferred from SB to MV. Subsequently, the plaque will be fixed by the expansive stent in MV.As to the provisional T treatment, provisional T stenting is the typic step-T stenting. In brief, two wires are advanced to distal MV and SB. Predilation is left at operator's discretion, however, predilating SB is not encouraged. Kissing balloon inflation before stenting MV is left at operator's discretion. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI is recommended if there is at least one of following: residual stenosis>75%, >type B dissection and TIMI flow<3.
All patients will be followed clinically at 1-, 6- 12- and 24-month after stent implantation. Repeat angiographic follow-ups are recommended for all patients at 12 months after the index procedure.
The primary endpoint of the trial is the rate of TLR at 12-month follow-up.
- Conditions
- Coronary Heart Disease
- Being tested
- Sirolimus Drug-eluting Stent via Active Transfer of Plaque, Sirolimus Drug-eluting Stent implantation via Provisional T Stenting
- Keywords
- Active Transfer of Plaque
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus Drug-eluting Stent via Active Transfer of PlaqueProcedure or surgery
Sirolimus Drug-eluting Stent implantation via Provisional T StentingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ATP technique | Experimental | This arm plan to enroll 158 subjects. Sirolimus-eluting Drug stent implantation via Active transfer of Plaque technique in the treatment of non-left-main bifurcation lesion.In the ATP technique treatment of bifurcation lesions, by the balloon pre-dilation in the target side branch, the plaque will be actively transferred from side branch to main vessel. Subsequently, the plaque will be fixed by the expansive stent in main vessel. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI or stent in SB is recommended if there is at least one of following: residual stenosis>75%, >type B dissection and TIMI flow<3. Receives: Procedure: Sirolimus Drug-eluting Stent via Active Transfer of Plaque |
| Provisional T stenting technique | Active comparator | This arm plan to enroll 158 subjects. Sirolimus-eluting Drug stent implantation via Provisional T stenting technique in the treatment of non-left-main bifurcation lesions.Provisional T stenting technique is the typic step-T stenting. In brief, two wires are advanced to distal MV and SB. Pre dilation is left at operator's discretion, however, pre dilating SB is not encouraged. Kissing balloon inflation before stenting MV is left at operator's discretion. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI is recommended if there is at least one of following: residual stenosis>75%, >type B dissection and TIMI flow<3. Receives: Procedure: Sirolimus Drug-eluting Stent implantation via Provisional T Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion revascularization(TLR) rate at 12 months post-procedure
Measured: 12 months
Secondary outcomes (6)
Rate of target lesion failure (TLF) at 30days, 6 months, and 24 months, including cardiac death, MI and ischemic TLR.
Measured: Up to 2 years
Clinically cardiovascular endpoints at 1-, 6- , 12- and 24-month, including all-cause death, MI and TLR.
Measured: Up to 2 years
Stent thrombosis which is defined according to Academic Research Consortium (ARC) definition, including definite, probable and possible stent thrombosis.
Measured: Up to 2 years
New York Heart Association classification of cardiac function.
Measured: Up to 2 years
Classification score of Canadian Cardiovascular Society (CCS) angina or Braunwald class.
Measured: Up to 2 years
In-stent lumen late loss, in-segment and in-stent restenosis rate 12 months after procedure
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 posted11 May 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (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.
- More trials run by Beijing Anzhen 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Qing, Beijing Anzhen Hospital
- Investigators
- Yujie Zhou, MD, PhD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768116
- Sponsor's protocol ID
- ATP Trial
- Status last verified
- Jan 2020
- First submitted
- 9 May 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Trial Comparing Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT02768116
- Acronym / sponsor ID
- ATP Trial
- Conditions
- Coronary Heart Disease
- Keywords
- Active Transfer of Plaque
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 May 2016 (estimated)
- 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.
A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary Bifurcation Lesions.
Detailed description
A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary Bifurcation Lesions.
The purpose of this trial is to evaluate the efficacy and safety of Active Transfer of Plaque and provisional T stenting techniques treating non-left-main coronary bifurcation lesions based on TLR rate 12-months post-procedure.
Provisional T Stenting is a common technique in BL treatment. Active Transfer of Plaque or ATP was reported, but there are no comparison between two procedure. In the ATP treatment of bifurcation lesions, two wires are advanced to distal main vessel (MV) and side branch(SB). Stent and balloon are advanced to MV and SB respectively. The MV stent is released while dilating the SB balloon. By predilating the balloon in the target SB, the plaque will be actively transferred from SB to MV. Subsequently, the plaque will be fixed by the expansive stent in MV.As to the provisional T treatment, provisional T stenting is the typic step-T stenting. In brief, two wires are advanced to distal MV and SB. Predilation is left at operator's discretion, however, predilating SB is not encouraged. Kissing balloon inflation before stenting MV is left at operator's discretion. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI is recommended if there is at least one of following: residual stenosis>75%, >type B dissection and TIMI flow<3.
All patients will be followed clinically at 1-, 6- 12- and 24-month after stent implantation. Repeat angiographic follow-ups are recommended for all patients at 12 months after the index procedure.
The primary endpoint of the trial is the rate of TLR at 12-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATP technique | Experimental | Procedure: Sirolimus Drug-eluting Stent via Active Transfer of PlaqueThis arm plan to enroll 158 subjects. Sirolimus-eluting Drug stent implantation via Active transfer of Plaque technique in the treatment of non-left-main bifurcation lesion.In the ATP technique treatment of bifurcation lesions, by the balloon pre-dilation in the target side branch, the plaque will be actively transferred from side branch to main vessel. Subsequently, the plaque will be fixed by the expansive stent in main vessel. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI or stent in SB is recommended if there is at least one of following: residual stenosis>75%, >type B dissection and TIMI flow<3. |
| Provisional T stenting technique | Active comparator | Procedure: Sirolimus Drug-eluting Stent implantation via Provisional T StentingThis arm plan to enroll 158 subjects. Sirolimus-eluting Drug stent implantation via Provisional T stenting technique in the treatment of non-left-main bifurcation lesions.Provisional T stenting technique is the typic step-T stenting. In brief, two wires are advanced to distal MV and SB. Pre dilation is left at operator's discretion, however, pre dilating SB is not encouraged. Kissing balloon inflation before stenting MV is left at operator's discretion. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI is recommended if there is at least one of following: residual stenosis>75%, >type B dissection and TIMI flow<3. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient must be at least >18, ≤80 years of age.
- Patient has Stable/unstable angina or NSTEMI.
- Patient has STEMI>24-hour from the onset of chest pain to admission.
- Non-left-main coronary bifurcation lesion. (Medina 0,1,1;1,1,1;1,0,1;1,1,0).
- Patient is eligible for elective percutaneous coronary intervention (PCI) .
Key exclusion criteria (9 listed)
- Patient with STEMI (within 24-hour from the onset of chest pain to admission).
- Patient has known allergy to the study stent system or protocol-required concomitant medications that cannot be adequately pre-medicated (everolimus, aspirin, contrast media, acrylic acid, Stainless steel).
- Patient has intolerable to dual anti-platelet therapy.
- Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
- Patient is pregnant or nursing.
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 |
|---|---|---|
| Sirolimus Drug-eluting Stent via Active Transfer of Plaque | Procedure or surgery | ATP technique |
| Sirolimus Drug-eluting Stent implantation via Provisional T Stenting | Procedure or surgery | Provisional T stenting technique |
Primary outcome
Target lesion revascularization(TLR) rate at 12 months post-procedure
Time frame: 12 months
6 secondary outcomes
Rate of target lesion failure (TLF) at 30days, 6 months, and 24 months, including cardiac death, MI and ischemic TLR.
Time frame: Up to 2 years
Clinically cardiovascular endpoints at 1-, 6- , 12- and 24-month, including all-cause death, MI and TLR.
Time frame: Up to 2 years
Stent thrombosis which is defined according to Academic Research Consortium (ARC) definition, including definite, probable and possible stent thrombosis.
Time frame: Up to 2 years
New York Heart Association classification of cardiac function.
Time frame: Up to 2 years
Classification score of Canadian Cardiovascular Society (CCS) angina or Braunwald class.
Time frame: Up to 2 years
In-stent lumen late loss, in-segment and in-stent restenosis rate 12 months after procedure
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 18 Jan 2020.
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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.
Yujie Zhou, MD, PhD principal investigator
Beijing Anzhen Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus Drug-eluting Stent via Active Transfer of Plaque and Sirolimus Drug-eluting Stent implantation via Provisional T Stenting in people with Coronary Heart Disease, run by Beijing Anzhen Hospital.
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 7 inclusion and 9 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Target lesion revascularization(TLR) rate at 12 months post-procedure (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 18 Jan 2020.