RESOLUTE China Registry:

NCT01243749 | Completed DMC

• 1 other identifier: IP124
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 6

Brief Summary

To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a real-world patient population requiring stent implantation.

Conditions

Ischemic Heart Disease; Stenotic Coronary Lesion; Cardiovascular Diseases; Arteriosclerosis; Coronary Artery Disease

Keywords

Target Vessel Revascularization (TVR); Target Lesion Revascularization (TLR); Myocardial Infarction (MI); Target Vessel Failure (TVF); Target Lesion Failure (TLF); Stent Thrombosis; Restenotic Lesion; Percutaneous Coronary Intervention (PCI); Real-world

Outcome Measures

Primary Outcomes (1)

• Target lesion failure (TLF)

  Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods at 1 year.

  12m

Secondary Outcomes (10)

• Overall stent thrombosis

  12m

• Device success, Lesion success, Procedural success

  At the end of the index procedure or during hospital stay

• TLF

  30 days, 6 months, 2 year, 3 year, 4 year and 5 year

• All deaths (cardiac, vascular and non-cardiovascular)

  30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year

• Stent thrombosis rate

  at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suitable for drug-eluting stent implantation according to the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the Resolute Zotarolimus-Eluting Coronary Stent System. All consecutive patients eligible for drug-eluting stent implantation with the elective use of the Resolute stent in one or more target lesions are candidates to be enrolled.

You may qualify if:

• Patient must meet all of the following criteria to be eligible for treatment in the trial:
• Age ≥ 18 years or minimum age as required by local regulations
• The patient 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 stent and the Declaration of Helsinki
• The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
• Intention to electively implant at least one Resolute stent
• The patient is willing and able to cooperate with study procedures and required follow up visits

You may not qualify if:

• Patients will be excluded from the trial if any of the following criteria are met:
• Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. Biolinx), zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media
• Women with known pregnancy or who are lactating
• High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
• Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
• Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
• Previous enrollment in the Resolute China Registry

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (6)

Beijing Fumwai Hospital

Beijing, 100000, China

Location

Peiking University People's Hospital

Beijing, 100044, China

Location

Fujian Medical University Union Hospital

Fuzhou, 350001, China

Location

Guangdong Provincial People's Hospital

Guangdong, 510000, China

Location

Nanjing First Hospital

Nanjing, 210006, China

Location

Wuhan Asia Heart Hospital

Wuhan, 430022, China

Location

Related Publications (1)

• Qiao S, Chen L, Chen S, Wang W, Zhu G. One-year outcomes from an all-comers chinese population of patients implanted with the resolute zotarolimus-eluting stent. Am J Cardiol. 2014 Feb 15;113(4):613-20. doi: 10.1016/j.amjcard.2013.10.042. Epub 2013 Nov 23.

  PMID: 24365120 RESULT

MeSH Terms

Conditions

Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Shubin Qiao, MD

  Fu Wai Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

• Jiyan Chen, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Lianglong Chen, MD

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

• Shaoliang Chen, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Weimin Wang, MD

  Peiking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Guoying Zhu, MD

  Wuhan Asia Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 18, 2010
• Study Start: December 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: December 15, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

CN (6)