An interventional study of Sirolimus eluting Drug stent in Coronary Heart Disease, sponsored by Beijing Anzhen Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment
A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions
It is a prospective, multi-center, randomized, open-label, non-inferiority trial. A total of 316 subjects from around 20 selected hospitals will be randomized on a 1:1 basis to either Active transfer of Plaque (ATP) stenting technique or Provisional T stenting technique.
In the ATP 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.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. 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>70%, >type B dissection and TIMI flow\<3.
All patients will be followed clinically at 1-, 6- 12- and 24-month after stent implantation. Repeat angiography will be performed in all patients at 13 months after the index procedure.
The primary endpoint of the trial is the rate of TLR at 12-month follow-up.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 316 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Beijing Anzhen Hospital is the lead sponsor of 188 studies on the registry; 100 are open to participants now.
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Exclusion Criteria:
This arm plan to enroll 158 subjects，Sirolimus-eluting Drug stent implantation via Active transfer of Plaque technique in the treatment of unprotected distal left main bifurcation lesions.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\>70%, \>type B dissection and TIMI flow\<3.
Device: Sirolimus eluting Drug stent
This arm plan to enroll 158 subjects.Sirolimus-eluting Drug stent implantation via Provisional T Stenting technique in the treatment of unprotected distal 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\>70%, \>type B dissection and TIMI flow\<3.
Device: Sirolimus eluting Drug stent
Use the Sirolimus-eluting Drug stents has been approved by the CFDA，But does not allow use taxol-eluting Drug stents and Drug-eluting stent without Polymer.
Rate of target lesion revascularization (TLR) at 12-month.
Time frame: 12 months
Rate of target lesion failure(TLF) at 1-, 6-,12- and 24-month after procedure
Time frame: Up to 2years
Clinically cardiovascular endpoints at 1-, 6- , 12- and 24-month, including all-cause death, MI and any revascularization.
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
Classification score of Canadian Cardiovascular Society (CCS) angina or Braunwald class.
Time frame: Up to 2 years
The net gain of lumen diameter; in-segment late loss (LL) and ISR of main vessel and side branch at 13-month.
Time frame: 13 months
The release of procedure-related biomarker
Time frame: baseline
Consumption of devices for surgery procedure
Time frame: baseline
Amount of contrast agent
Time frame: baseline
Procedure time
Time frame: baseline
X-ray exposure time
Time frame: baseline
X-ray dose
Time frame: baseline
DAP-total, DAP-record, DAP-fluoro
Time frame: baseline
contrast induced acute kidney injury (CIAKI)
Time frame: 3 days after the procedure
Plan to share: Undecided
No publications or documents are linked to this record.
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Beijing Anzhen Hospital