RESOLUTE China RCT

NCT01334268 | Completed DMC

• 1 other identifier: IP 10009066DOC
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation.

Conditions

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

Keywords

In-stent Late Lumen Loss (LLL); TARGET VESSEL FAILURE (TVF); MYOCARDIAL INFARCTION (MI); TARGET VESSEL REVASCULARIZATION (TVR); TARGET LESION REVASCULARIZATION (TLR); TARGET LESION FAILURE (TLF); STENT THROMBOSIS; RESTENOTIC LESION; PERCUTANEOUS CORONARY INTERVENTION (PCI); REAL-WORLD; THE RANDOMIZED CONTROLLED TRIAL

Outcome Measures

Primary Outcomes (1)

• in-stent late lumen loss (LLL)

  in-stent late lumen loss (LLL), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD.

  9 months

Secondary Outcomes (11)

• Device success

  at the end of the index procedure or during hospital stay

• Death

  30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr

• Myocardial infarction

  30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr

• MACE composite endpoint

  30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr

• Composite endpoint of (all cause) mortality, Myocardial Infarction (Q-wave and non Q-wave) or (any) revascularization

  30d, 6m, 12m, 2yr, 3yr, 4yr, 5yr

Study Arms (2)

Taxus Liberte Paclitaxel-Eluting Coronary Stent System

ACTIVE COMPARATOR

Subjects will be randomized to be treated with Taxus Liberte Paclitaxel-Eluting Coronary Stent System by an interactive voice response system (IVRS).

Device: Taxus Liberte Paclitaxel-Eluting Coronary Stent System

Medtronic Resolute (Zotarolimus-eluting stent)

EXPERIMENTAL

Subjects will be randomized to be treated with Medtronic Resolute (Zotarolimus-eluting stent) by an interactive voice response system (IVRS).

Device: Resolute Zotarolimus-Eluting Coronary Stent System

Interventions

Taxus Liberte Paclitaxel-Eluting Coronary Stent System DEVICE

Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation

Also known as: Taxus

Taxus Liberte Paclitaxel-Eluting Coronary Stent System

Resolute Zotarolimus-Eluting Coronary Stent System DEVICE

Resolute Zotarolimus-Eluting Coronary Stent System Implantation

Also known as: Resolute

Medtronic Resolute (Zotarolimus-eluting stent)

Eligibility Criteria

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

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 Taxus Liberte 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 or Taxus Liberte 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, 316L stainless steel, polymer coatings (e.g. Biolinx), zotarolimus, paclitaxel, 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 RCT

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (4)

An Zhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Beijing Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

First Affiliated Hospital of Medical College of XI'AN Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (1)

• Xu B, Yang Y, Yuan Z, Du Z, Wong SC, Genereux P, Lu S; RESOLUTE China RCT Investigators. Zotarolimus- and paclitaxel-eluting stents in an all-comer population in China: the RESOLUTE China randomized controlled trial. JACC Cardiovasc Interv. 2013 Jul;6(7):664-70. doi: 10.1016/j.jcin.2013.03.001. Epub 2013 Mar 21.

  PMID: 23523240 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

• Shuzheng Lv

  An Zhen Hospital

  PRINCIPAL INVESTIGATOR

• Yundai Chen

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Zhimin Du

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Bo Xu

  Beijing Fu Wai Hospital

  PRINCIPAL INVESTIGATOR

• Yuejin Yang, MD

  Fu Wai Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

• Zuyi Yuan

  First Affiliated Hospital of Medical College of ZI'AN Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 13, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: June 30, 2017
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

CN (4)