NCT02127138

The Study of Active Transfer of Plaque Technique for Unprotected Distal Left Main Bifurcation Lesions

A Prospective Multicenter 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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 316 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 Unprotected Distal Left Main Bifurcation Lesions

Detailed description

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.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2014-04-30
• Last updated: 2020-01-18

Locations

1 site across 1 country: China