NCT04617899

Brief Summary

This prospective, multicenter, single-arm study aims to evaluate the safety, operability and practicability of the novel hybrid intravascular imaging system/catheter during the percutaneous transluminal coronary intervention.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

4 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 17, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

October 21, 2020

Last Update Submit

May 28, 2021

Conditions

Coronary Artery Disease

Keywords

Intravascular imagingIntravascular ultrasoundOptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • Clear image length measured by Core lab

    The clear image length is transformed from the clear image frame, and the ratio of the clear image can be calculated by Clear image length / Full image length \* 100%

    During the procedure

Secondary Outcomes (7)

  • Catheter-related major adverse events

    Periprocedure

  • Clear stent length measured by Core lab

    During the procedure

  • Device Success

    During the procedure

  • Technical Success

    During the procedure

  • Image quality evaluated by operator

    During the procedure

  • +2 more secondary outcomes

Study Arms (1)

Novasight IVUS/OCT

EXPERIMENTAL

A coronary segment with stent will be imaged by the Novasight IVUS/OCT catheter

Diagnostic Test: Intravascular imaging

Interventions

Intravascular imagingDIAGNOSTIC_TEST

Use of imaging catheter

Novasight IVUS/OCT

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be at least 18 years of age and less than 85 years of age.
  • Subject must be informed and sign a written consent
  • Subject must have evidence of myocardial ischemia, unstable angina or acute myocardial infarction suitable for PCI.

You may not qualify if:

  • Women who are pregnant or cannot eliminate the possibility to be pregnant.
  • Estimated creatinine clearance \<30 ml/min/1.73 m2 using Cockcroft equation.
  • LVEF(Left ventricular ejection fraction) \< 35% by the most recent imaging test within 7 days prior to procedure.
  • Unstable ventricular arrhythmias.
  • High bleeding risk, active peptic ulcers or cerebrovascular accident or transient ischemic attack within the past 6 months.
  • Known contraindication to anticoagulants and antiplatelets therapy.
  • Known hypersensitivity to aspirin, clopidogrel, heparin, iodinated contrast, ticagrelor, bivalirudin, metal materials in stent.
  • Any intervention for not target vessel within 48 hours after the study procedure.
  • Any conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation.
  • The reference diameter of target vessel is less than 2.5 mm.
  • The target lesion involves myocardial bridge.
  • The target lesion is in the left main coronary artery or the damage is observed in the ostium.
  • Severe calcification in the target vessel.
  • Severe tortuosity in the target vessel.
  • Multiple contiguous stent implantation in the target vessel.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Chaoyang District, 100029, China

RECRUITING

Beijing Tiantan Hospital, Capital Medical University

Beijing, Fengtai District, 100050, China

NOT YET RECRUITING

Chinese PLA General Hospital

Beijing, Haidian District, 100039, China

RECRUITING

Peking University Third Hospital

Beijing, Haidian District, China

RECRUITING

Related Publications (1)

  • Jin Q, Fu Z, Wang Y, Zeng Y, Zhang X, Ye Y, Tang Y, Xu X, Chen Y. A Multicenter Feasibility and Safety Study of a Novel Hybrid IVUS-OCT Imaging System. JACC Asia. 2025 Mar;5(3 Pt 1):396-400. doi: 10.1016/j.jacasi.2025.01.009.

    PMID: 40049934DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Muyan Zou

CONTACT

0086-15564579827zoumuyan@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2020

First Posted

November 5, 2020

Study Start

March 17, 2021

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

June 1, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

According to the policy of the Human Genetic Resource Administration of China, the data is limited and it could not be shared currently.

Locations

CN(4)