Antegrade and Retrograde Dissection and Re-entry Approach for CTO (LOTUS)
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|ClinicalTrials.gov Identifier: NCT03769038|
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 19, 2018
BACKGROUND：Chronic total occlusion (CTO) angioplasty is one of the most challenging procedures remaining for the interventional operator. Today, with contemporary CTO negotiation available strategies and significant operator expertise, the literature reports a 50%-95% success rate for recanalizing CTOs. But PCIs of CTO lesions still carry a high rate of in-stent restenosis (ISR). Because previous reports have not specifically compare contemporary antegrade and retrograde dissection and re-entry dissection (ADR/RDR) technique on the long-term impact of ISR, so the investigators focused on the objective.
OBJECTIVES: This study hope to evaluate the frequency of angiographic ISR and further elucidate some ISR related higher risk factors among CTO PCI patients in intimal stent group using antegrade or retrograde wire escalation (AWE/RWE) techniques and sub-intimal stent group using contemporary antegrade or retrograde dissection and re-entry (ADR and/or RDR).
METHODS: A total of 300 consecutive selected patients with CTO lesion who will undergo successful revascularization by AWE/RWE and ADR/RDR techniques treatment will be enrolled in this prospective multicenter registry from December 1 2018 to December 31 2019. The primary study endpoint of the protocol is the bionary in-stent restenosis of CTO vessels at angiographic follow-up about 13 months. The secondary endpoints are: 1) CTO technique and procedure success rate; and 2) in-hospital and 30 days MACE (Cardiac death, acute myocardial infarction, urgent repeat tratget vessel revascularization with either pericardiocentssis or surgery and stroke and stent thrombosis and stroke); 6months and 1-year and 2-year MACE including death, MI, and target CTO vessel revascularization and stroke ; and 3) Restenosis scores (R-scores) of related risk factors.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Total Occlusion of Coronary Artery||Device: chronic total occlusion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Outcomes of Successful Chronic Total Occlusion Percutaneous Coronary Interventions Using the Antegrade and Retrograde Dissection and Re-entry Approach|
|Estimated Study Start Date :||December 15, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Chronic Total Occlusion and Restenosis
contemporary antegrade or retrograde dissection and re-entry (ADR or RDR) to open CTO
Device: chronic total occlusion
chronic total occlusion of coronary atery was opened and then stents were placed
- the bionary in-stent restenosis of CTO vessels at the scheduled angiographic follow-up at 13 months. [ Time Frame: 13months after PCI ]the diamater of stents less than 50%