MedTrace Logo

Antegrade and Retrograde Dissection and Re-entry Approach for CTO

NCT03769038 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-11-01

No results posted yet for this study

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.

Conditions

  • Chronic Total Occlusion of Coronary Artery

Interventions

DEVICE

chronic total occlusion

chronic total occlusion of coronary atery was opened and then stents were placed

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-12-31
Completion
2022-09-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03769038 on ClinicalTrials.gov