Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial

NCT01196819 | Completed Results DMC

• 1 other identifier: Target I
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 9 Months In-stent Late Lumen Loss

  To observe in-stent late lumen loss after 9 months of stent implantation It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure

  9 months

Secondary Outcomes (7)

• 9 Months In-stent Diameter Stenosis

  9 months

• Target Lesion Failure(TLF) Rate

  1 years after index PCI

• TLF(Target Lumen Failure) Rate

  3 years after index PCI (Percutaneous Coronary Intervention)

• TLF(Target Lumen Failure)

  5 years after index PCI

• Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)

  1 years after index PCI

Study Arms (2)

Xience V

ACTIVE COMPARATOR

Implantation of Xience V drug eluting stent

Device: Xience V

Firehawk

EXPERIMENTAL

Implantation of Firehawk drug eluting stent

Device: Firehawk

Interventions

Firehawk DEVICE

Implantation of Firehawk drug eluting stent

Firehawk

Xience V DEVICE

Implantation of Xience V drug eluting stent

Xience V

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75, male or women who are not pregnant
• Evidence of non-symptomatic ischemia, stable or non-stable angina or past heart attack cases
• Target lesion is primary, single artery and single lesion of coronary artery
• Target lesion vessel length ≤24mm, diameter 2.25mm-4.0mm
• Lesion diameter stenosis ≥70%
• Candidates understand the study, willing to sign Consent of Agreement and to willing to accept follow-up For long lesion group, at least one target lesion length ≥28mm，diameter 2.5mm-4.0mm, and one lesion needs to implant 33mm 0r 38mm long stent

You may not qualify if:

• Acute heart attack within one week
• Chronic complete stenosis (TIMI 0), left main lesion, three branches need to treat, branch vessel diameter ≤2.5mm and bypass lesion
• Calcified lesion failed in pre-dilation and twisted lesion
• In-stent restenosis
• Stent implanted within one year
• Severe heart failure (NYHA above III) or left ventricle EF \<40%
• Renal function damage, blood creatinine \>2.0mg/dl
• Bleeding risk; allergic to drugs and agents used in procedure/treatment
• Life expectation \< 12 months
• No compliances to the protocol
• Heart implantation cases
• Patients underwent 9-month angio F/U
• No binary restenosis at 9-month
• LLL between -0.01\~0.2mm
• No mix-implanted stent

Sponsors & Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.: lead

Study Sites (1)

Fuwai Hospital

Beijing, 100037, China

Location

Related Publications (3)

• Li CJ, Xu B, Guan CD, Gao RL; TARGETⅠTrial Investigators. [Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions]. Zhonghua Xin Xue Guan Bing Za Zhi. 2017 Nov 24;45(11):940-947. doi: 10.3760/cma.j.issn.0253-3758.2017.11.009. Chinese.

  PMID: 29166720 DERIVED

• Gao Z, Zhang R, Xu B, Yang Y, Ma C, Li H, Chen S, Han Y, Yuan Z, Lansky AJ, Guan C, Leon MB, Gao R; TARGET Investigators. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:734-43. doi: 10.1002/ccd.25861. Epub 2015 Feb 19.

  PMID: 25678281 DERIVED

• Gao RL, Xu B, Lansky AJ, Yang YJ, Ma CS, Han YL, Chen SL, Li H, Zhang RY, Fu GS, Yuan ZY, Jiang H, Huo Y, Li W, Zhang YJ, Leon MB; TARGET I Investigators. A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial. EuroIntervention. 2013 May 20;9(1):75-83. doi: 10.4244/EIJV9I1A12.

  PMID: 23685298 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Kefei Li
• Organization: Shanghai Microport Medical (Group) Co.,Ltd.

kfli@microport.com

+86-21-38954600×6700

Study Officials

• Runlin Gao, Pro & MD

  Fuwai Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 6, 2010
• First Posted: September 8, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: December 1, 2016
• Last Updated: July 30, 2019
• Results First Posted: February 22, 2018

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)