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SUPERIOR: The StUdy to Evaluate the Performance and safEty of the Novasight HybRid System Using Objective PeRformance Criteria

Sponsor
CardioNavi MedTech (Wuhan) Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04617899
Collaborator
Beijing Jingruitianhe Medical Science and Technology Development Co,Ltd (Other)
120
Enrollment
4
Locations
1
Arm
9.5
Anticipated Duration (Months)
30
Patients Per Site
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Intravascular imaging
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Study to Evaluate the Performance and Safety of the Novasight Hybrid System Using Objective Performance Criteria
Actual Study Start Date :
Mar 17, 2021
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Novasight IVUS/OCT

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

Diagnostic Test: Intravascular imaging
Use of imaging catheter

Outcome Measures

Primary Outcome Measures

  1. Clear image length measured by Core lab [During the procedure]

    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%

Secondary Outcome Measures

  1. Catheter-related major adverse events [Periprocedure]

    Cardiac death, myocardial infarction, blood-limited dissection

  2. Clear stent length measured by Core lab [During the procedure]

    Clear stent length is defined as the total stent length visualized within the clear image length.

  3. Device Success [During the procedure]

    Successfully deliver the catheter to the target lesion and withdrawal without fracture

  4. Technical Success [During the procedure]

    Successfully imaging

  5. Image quality evaluated by operator [During the procedure]

    Objective and subjective assessment of image quality.

  6. System reliability evaluated by operator [During the procedure]

    Objective and subjective assessment of system reliability.

  7. Catheter operability evaluated by operator [During the procedure]

    Objective and subjective assessment of catheter operability.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Subject must be at least 18 years of age and less than 85 years of age.

  2. Subject must be informed and sign a written consent

  3. Subject must have evidence of myocardial ischemia, unstable angina or acute myocardial infarction suitable for PCI.

Exclusion Criteria:

  1. Women who are pregnant or cannot eliminate the possibility to be pregnant.

  2. Estimated creatinine clearance <30 ml/min/1.73 m2 using Cockcroft equation.

  3. LVEF(Left ventricular ejection fraction) < 35% by the most recent imaging test within 7 days prior to procedure.

  4. Unstable ventricular arrhythmias.

  5. High bleeding risk, active peptic ulcers or cerebrovascular accident or transient ischemic attack within the past 6 months.

  6. Known contraindication to anticoagulants and antiplatelets therapy.

  7. Known hypersensitivity to aspirin, clopidogrel, heparin, iodinated contrast, ticagrelor, bivalirudin, metal materials in stent.

  8. Any intervention for not target vessel within 48 hours after the study procedure.

  9. Any conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation.

Angiographic exclusion criteria:

  1. The reference diameter of target vessel is less than 2.5 mm.

  2. The target lesion involves myocardial bridge.

  3. The target lesion is in the left main coronary artery or the damage is observed in the ostium.

  4. Severe calcification in the target vessel.

  5. Severe tortuosity in the target vessel.

  6. Multiple contiguous stent implantation in the target vessel.

  7. Subject has coronary artery spasm.

  8. In-stent restenosis.

  9. Any study lesion characteristic that, in the investigator's opinion, is not available for intravascular imaging.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Anzhen Hospital, Capital Medical University Beijing Chaoyang District China 100029
2 Beijing Tiantan Hospital, Capital Medical University Beijing Fengtai District China 100050
3 Chinese PLA General Hospital Beijing Haidian District China 100039
4 Peking University Third Hospital Beijing Haidian District China

Sponsors and Collaborators

  • CardioNavi MedTech (Wuhan) Co., Ltd.
  • Beijing Jingruitianhe Medical Science and Technology Development Co,Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CardioNavi MedTech (Wuhan) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04617899
Other Study ID Numbers:
  • CardioNavi
First Posted:
Nov 5, 2020
Last Update Posted:
Jun 1, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by CardioNavi MedTech (Wuhan) Co., Ltd.
Intravascular imaging
Intravascular ultrasound
Optical coherence tomography
Additional relevant MeSH terms:
Coronary Artery Disease

Study Results

No Results Posted as of Jun 1, 2021