A Prospective Randomized Multicenter Non-inferiority Clinical Study to Determine the Safety and Performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter (Hemoteq) Compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter (B.Braun) for the Treatment of Coronary In-Stent Restenosis (AGENT-ISR)

Hemoteq AG12 sites in 2 countries123 target enrollmentAugust 13, 2014

ConditionsCoronary Artery Disease Coronary Restenosis Coronary Atherosclerosis Coronary Arteriosclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Hemoteq AG
Enrollment: 123
Locations: 12
Primary Endpoint: in-stent late lumen loss
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented coronary arteries (in-stent restenosis).

The performance will be determined at six months post-procedure by quantitative coronary angiography (QCA) to measure Late Lumen Loss (LLL) in the re-opened stented segment. QCA results will be assessed by an independent, blinded angiographic core lab.

Study statistical hypothesis: The loss of in-stent luminal diameter at six months after treatment of the restenosed stent with the Agent™ study device is not larger than the respective LLL after treatment with the SeQuent® Please control devices, i.e. study device is non-inferior to the control device with respect to LLL.

Registry

clinicaltrials.gov

Start Date

August 13, 2014

End Date

October 28, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hemoteq AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be at least 18 years of age
•Subject is willing and able to provide informed consent
•Subject is eligible for percutaneous coronary intervention
•Subject is willing to comply with all protocol-required follow-up evaluations
•Women of child-bearing potential must agree to use a reliable method of contraception
•In-stent restenosis in a lesion previously treated with either a drug-eluting or bare metal stent, located in a native coronary artery with a reference vessel diameter ≥ 2.0 mm and ≤ 3.5 mm
•Target lesion length must be ≤ 28 mm (by visual estimate) and must be covered by only one balloon
•Target lesion must have visually estimated stenosis ≥ 70% and \< 100% in asymptomatic patients
•Target lesion must have visually estimated stenosis ≥ 50% and \< 100% in symptomatic patients
•Thrombolysis in Myocardial Infarction (TIMI) grade flow in the target lesion must be ≥ 1

Exclusion Criteria

•Patient has life expectancy of less than 24 months
•Patient with known coronary artery spasm
•Patient with unprotected left main coronary artery disease
•Patient has current problems with substance abuse
•Patient has planned procedure that may cause non-compliance with the protocol or confound data interpretation
•Patient is participating in another investigational drug or device clinical study that has not reached its primary endpoint
•Patient intends to participate in another investigational drug or device clinical study within 12 months after the index procedure
•Woman who is pregnant or nursing
•Left ventricular ejection fraction \< 25%
•Patient had PCI or other coronary interventions within the last 30 days

Outcomes

Primary Outcomes

in-stent late lumen loss

Time Frame: six months

In-stent late lumen loss (LLL) of the treated stented segment after PTCA using the Agent(TM) study device in comparison to the LLL after PTCA using the SeQuent(R) Please control device as measured by QCA at six months post-index procedure.

Secondary Outcomes

Target lesion revascularization (TLR) rate(36 months)
Target vessel revascularization (TVR) rate(36 months)
Cardiac, non-cardiac and all death rates(36 months)
In-segment minimal lumen diameter (MLD)(6 months post-index procedure)
technical success rate(during index procedure, less 1 hour)
clinical procedural success rate(within 24 hours of index procedure)
In-stent percent diameter stenosis(6 months post-index procedure)
In-stent minimal lumen diameter (MLD)(6 months post-index procedure)
In-segment percent diameter stenosis(6 months post-index procedure)
In-stent binary restenosis rate(6 months post-index procedure)
In-segment binary restenosis rate(6 months post-index procedure)
In-segment late lumen loss(6 months post-index procedure)
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)(36 months)
Stent thrombosis rate (by ARC definition)(36 months)
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)(36 months)
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)(36 months)
Change in Quality of Life(36 months)