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Antegrade and Retrograde Dissection and Re-entry Approach for CTO (LOTUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03769038
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 19, 2018
Information provided by (Responsible Party):
Xijing Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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%

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CTO time >3months and CTO length >20mm

Exclusion Criteria:

  • age <18-years-old or >85-years-old,
  • left ventricular ejection fraction ≦30%,
  • allergy to medications (antiplatelet drugs, heparin, metal alloys, or contrast agents),
  • a planned surgery within 6 months of PCI or planned thrombolysis,

    • pregnant,
    • a life expectancy of <6 months.
  Study Documents (Full-Text)

Documents provided by Xijing Hospital:
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Responsible Party: Xijing Hospital Identifier: NCT03769038    
Other Study ID Numbers: XJYY-LL-FJ-059
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No