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China Resolute Integrity 34/38 mm Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118531
Recruitment Status : Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Brief Summary:
To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Stenotic Coronary Lesion Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Clinical Safety and Efficacy of the 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Subjects According to the Indication for Use
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : July 31, 2018
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Coronary Stent
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (34/38 mm)
Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)
The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent.




Primary Outcome Measures :
  1. Late lumen loss, in stent [ Time Frame: 9 months (m) ]
    Late lumen loss measured by quantitative coronary angiography (QCA)


Secondary Outcome Measures :
  1. Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years ]
    Defined as death, myocardial infarction (Q wave and non-Q wave), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods

  2. Death [ Time Frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years ]
    All death

  3. Myocardial infarction [ Time Frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years ]
    All MI, and Target Vessel Myocardial Infarction (TVMI)

  4. All revascularizations [ Time Frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years ]
    Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR

  5. Target Vessel Failure (TVF) [ Time Frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years ]
    TVF

  6. Target Lesion Failure (TLF) [ Time Frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years ]
    TLF

  7. Stent Thrombosis (ST) [ Time Frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years ]
    ST

  8. Device Success [ Time Frame: At the end of index procedure, an expected average of 3 days ]

    The attainment of <50% residual stenosis of the target lesion using only the assigned device.

    The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.


  9. Lesion Success [ Time Frame: At the end of index procedure, an expected average of 3 days ]

    The attainment of <50% residual stenosis of the target lesion using any percutaneous method.

    The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method. These measurements will be made by the independent angiographic core laboratory.


  10. Procedure Success [ Time Frame: Duration of hospital stay, an expected average of 5 days ]

    The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE.

    The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory.


  11. In-stent and in-segment percent diameter stenosis (%DS) [ Time Frame: 9 months ]
    In-stent and in-segment percent diameter stenosis (%DS)

  12. In-stent and in-segment binary restenosis rate [ Time Frame: 9 months ]
    In-stent and in-segment binary restenosis rate

  13. In-stent and in-segment minimal luminal diameter (MLD) [ Time Frame: 9 months ]
    In-stent and in-segment minimal luminal diameter (MLD)

  14. In-segment late luminal loss [ Time Frame: 9 months ]
    In-segment late luminal loss



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute Integrity 34/38 mm stent
  • The subject can have either a single lesion, or two lesions located in separate target vessels treated during the index procedure. Each lesion length needs to be ≤35mm with at least one lesion length >27mm and≤ 35mm and amenable for treatment with a Resolute Integrity 34/38 mm stent

Key Exclusion Criteria:

  • STEMI within 24 hours
  • Left main disease
  • Bifurcation disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118531


Locations
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China, Beijing
Beijing Friendship Hospital
Beijing, Beijing, China, 100000
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
China, Hubei
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
Sponsors and Collaborators
Medtronic Vascular
Investigators
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Principal Investigator: Lianglong Chen, MD Fujian Medical University Union Hospital
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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT03118531    
Other Study ID Numbers: MDT16003RES001
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medtronic Vascular:
Long Lesion
In-stent Late Lumen Loss (LLL)
Major Adverse Cardiac Events (MACE)
MYOCARDIAL INFARCTION (MI)
TARGET VESSEL REVASCULARIZATION (TVR)
TARGET LESION REVASCULARIZATION (TLR)
Target Vessel Failure (TVF)
Target Lesion Failure (TLF)
Stent Thrombosis (ST)
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Coronary Disease
Arterial Occlusive Diseases
Vascular Diseases