Antegrade and Retrograde Dissection and Re-entry Approach for CTO

NCT03769038 | Completed

• 1 other identifier: XJYY-LL-FJ-059
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Total Occlusion of Coronary Artery

Outcome Measures

Primary Outcomes (1)

• the bionary in-stent restenosis of CTO vessels at the scheduled angiographic follow-up at 13 months.

  the diamater of stents less than 50%

  13months after PCI

Study Arms (1)

Chronic Total Occlusion and Restenosis

OTHER

contemporary antegrade or retrograde dissection and re-entry (ADR or RDR) to open CTO

Device: chronic total occlusion

Interventions

chronic total occlusion DEVICE

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

Chronic Total Occlusion and Restenosis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

First affiliated hospital of fourth military medical university

Xi'an, Shaanxi, 710032, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: December 7, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: September 30, 2022
• Last Updated: November 1, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)