Overview

This trial is active, not recruiting.

Conditions coronary artery disease, coronary restenosis, coronary atherosclerosis, coronary arteriosclerosis
Treatments agent paclitaxel-coated balloon, sequent® please paclitaxel-coated balloon
Sponsor Hemoteq AG
Start date August 2014
End date December 2016
Trial size 123 participants
Trial identifier NCT02151812, CIV-13-11-011728, HTQ002-Agent-ISR

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
drug-coated balloon dilatation of the index lesion using a single Agent(TM) balloon that completely covers the restenotic lesion
agent paclitaxel-coated balloon
After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.
(Active Comparator)
drug-coated balloon dilatation of the index lesion using a single SeQuent(R) Please balloon that completely covers the restenotic lesion
sequent® please paclitaxel-coated balloon
After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.

Primary Outcomes

Measure
in-stent late lumen loss
time frame: six months

Secondary Outcomes

Measure
technical success rate
time frame: during index procedure, less 1 hour
clinical procedural success rate
time frame: within 24 hours of index procedure
In-stent percent diameter stenosis
time frame: 6 months post-index procedure
In-segment percent diameter stenosis
time frame: 6 months post-index procedure
In-stent binary restenosis rate
time frame: 6 months post-index procedure
In-segment binary restenosis rate
time frame: 6 months post-index procedure
In-segment late lumen loss
time frame: 6 months post-index procedure
In-stent minimal lumen diameter (MLD)
time frame: 6 months post-index procedure
In-segment minimal lumen diameter (MLD)
time frame: 6 months post-index procedure
Target lesion revascularization (TLR) rate
time frame: pre-discharge, estim. <10 days
Target lesion revascularization (TLR) rate
time frame: 30 days
Target lesion revascularization (TLR) rate
time frame: six months
Target lesion revascularization (TLR) rate
time frame: 12 months
Target lesion revascularization (TLR) rate
time frame: 24 months
Target lesion revascularization (TLR) rate
time frame: 36 months
Target vessel revascularization (TVR) rate
time frame: pre-discharge, estim. <10 days
Target vessel revascularization (TVR) rate
time frame: 30 days
Target vessel revascularization (TVR) rate
time frame: six months
Target vessel revascularization (TVR) rate
time frame: 12 months
Target vessel revascularization (TVR) rate
time frame: 24 months
Target vessel revascularization (TVR) rate
time frame: 36 months
Cardiac, non-cardiac and all death rates
time frame: pre-discharge, estim. <10 days
Cardiac, non-cardiac and all death rates
time frame: 30 days
Cardiac, non-cardiac and all death rates
time frame: six months
Cardiac, non-cardiac and all death rates
time frame: 12 months
Cardiac, non-cardiac and all death rates
time frame: 24 months
Cardiac, non-cardiac and all death rates
time frame: 36 months
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
time frame: pre-discharge, estim. <10 days
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
time frame: 30 days
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
time frame: six months
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
time frame: 12 months
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
time frame: 24 months
Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
time frame: 36 months
Stent thrombosis rate (by ARC definition)
time frame: pre-discharge, estim. <10 days
Stent thrombosis rate (by ARC definition)
time frame: 30 days
Stent thrombosis rate (by ARC definition)
time frame: six months
Stent thrombosis rate (by ARC definition)
time frame: 12 months
Stent thrombosis rate (by ARC definition)
time frame: 24 months
Stent thrombosis rate (by ARC definition)
time frame: 36 months
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
time frame: pre-discharge, estim. <10 days
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
time frame: 30 days
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
time frame: six months
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
time frame: 12 months
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
time frame: 24 months
Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
time frame: 36 months
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
time frame: pre-discharge, estim. <10 days
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
time frame: 30 days
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
time frame: six months
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
time frame: 12 months
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
time frame: 24 months
Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
time frame: 36 months
Change in Quality of Life
time frame: six months
Change in Quality of Life
time frame: 12 months
Change in Quality of Life
time frame: 24 months
Change in Quality of Life
time frame: 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 - Target lesion must be successfully pre-dilated. 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 - Planned PCI or CABG after the index procedure - Patient to receive other PCI interventions in the target vessel, such as rotablation, laser atherectomy, cutting balloon, DCB, DES, BMS, bioabsorbable scaffold etc. - Patient to receive DCB in non-target coronary vessels - Acute MI < 72h - Cardiogenic shock - Known allergies against Paclitaxel or other components of the used medical devices - Known hypersensitivity or contraindication for contrast dye that cannot be adequately pre-medicated - Intolerance to antiplatelet drugs, anticoagulants required for the procedure - Platelet count < 100k/mm3 or > 500k/mm3 - Patient with renal failure with a serum creatinine of > 2.5mg/dL who is receiving dialysis or chronic immunosuppressant therapy - Target lesion is located within a bifurcation involving a major side branch > 2 mm in diameter - Target lesion is located within a saphenous vein graft or an arterial graft - Target lesion with TIMI grade flow = 0 (total occlusion) - Thrombus present in the target vessel - > 50% stenosis of an additional lesion proximal or distal to the target lesion

Additional Information

Official title 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)
Principal investigator Christian W. Hamm, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Hemoteq AG.