NCT03229993

Brief Summary

To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation and treatment of angiographically borderline coronary artery lesions in a Chinese population, and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the participants included in the study will be those that are found to have borderline coronary artery lesions on coronary angiography, in whom the investigators feel that OCT will be useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or whether optimal medical therapy is the most appropriate treatment modality. Those participants who declined OCT will be offered SPECT as an alternative method to assess and treat the borderline coronary artery stenosis. It is estimated that OCT guided "PCI or not" has a non-inferiority to SPECT's in the borderline coronary artery stenosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

December 31, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

July 23, 2017

Last Update Submit

July 15, 2020

Conditions

Optical Coherence Tomography (OCT)Percutaneous Coronary Intervention (PCI)Single-Photon Emission Computed Tomography (SPECT)Coronary Angiography (CAG)Borderline Coronary Artery Lesions

Outcome Measures

Primary Outcomes (2)

  • MACEs

    The incidence of major adverse cardiac events (MACEs) including death, myocardial infarction, and stent thrombosis.

    12 months

  • TLR

    The incidence of target lesion revascularization (TLR)

    12 months

Secondary Outcomes (2)

  • Rehospitalization

    12 months

  • Recurrent angina

    12 months

Study Arms (4)

OCT guided PCI

EXPERIMENTAL
Diagnostic Test: OCT

OCT guided medicine

EXPERIMENTAL
Diagnostic Test: OCT

SPECT guided PCI

NO INTERVENTION

SPECT guided medicine

NO INTERVENTION

Interventions

OCTDIAGNOSTIC_TEST

OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions

OCT guided PCIOCT guided medicine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2017

First Posted

July 26, 2017

Study Start

December 31, 2017

Primary Completion

January 31, 2018

Study Completion

December 31, 2019

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

CN(1)