NCT02768116

The Study of Active Transfer of Plaque Technique for Non-Left Main Coronary Bifurcation Lesions

A Prospective Multicenter Randomized Trial Comparing Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary 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 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.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
PROCEDURE	Sirolimus Drug-eluting Stent via Active Transfer of Plaque
PROCEDURE	Sirolimus Drug-eluting Stent implantation via Provisional T Stenting

Timeline

• Start date: 2016-06-01
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2016-05-11
• Last updated: 2020-01-18