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OpenTrials
Completed

NCT Number: NCT03118531

China Resolute Integrity 34/38 mm Study

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.

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Key information

Conditions

Ischemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Stenotic Coronary Lesion Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Friendship Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)

Device

The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent.

Primary outcomes

  1. Late lumen loss, in stent

    Time frame: 9 months (m)

    Late lumen loss measured by quantitative coronary angiography (QCA)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2023
First posted
Apr 18, 2017
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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