Clinical trial NCT02151812: Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Restenosis
Coronary Atherosclerosis
Coronary Arteriosclerosis
Lead sponsor: Hemoteq AG
Sponsor class: INDUSTRY
First posted: 2014-05-30
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: in-stent late lumen loss
timeFrame: six months
Secondary outcomes:
measure: technical success rate
timeFrame: during index procedure, less 1 hour
measure: clinical procedural success rate
timeFrame: within 24 hours of index procedure
measure: In-stent percent diameter stenosis
timeFrame: 6 months post-index procedure
measure: In-segment percent diameter stenosis
timeFrame: 6 months post-index procedure
measure: In-stent binary restenosis rate
timeFrame: 6 months post-index procedure
measure: In-segment binary restenosis rate
timeFrame: 6 months post-index procedure
measure: In-segment late lumen loss
timeFrame: 6 months post-index procedure
measure: In-stent minimal lumen diameter (MLD)
timeFrame: 6 months post-index procedure
measure: In-segment minimal lumen diameter (MLD)
timeFrame: 6 months post-index procedure
measure: Target lesion revascularization (TLR) rate
timeFrame: pre-discharge, estim. <10 days
measure: Target lesion revascularization (TLR) rate
timeFrame: 30 days
measure: Target lesion revascularization (TLR) rate
timeFrame: six months
measure: Target lesion revascularization (TLR) rate
timeFrame: 12 months
measure: Target lesion revascularization (TLR) rate
timeFrame: 24 months
measure: Target lesion revascularization (TLR) rate
timeFrame: 36 months
measure: Target vessel revascularization (TVR) rate
timeFrame: pre-discharge, estim. <10 days
measure: Target vessel revascularization (TVR) rate
timeFrame: 30 days
measure: Target vessel revascularization (TVR) rate
timeFrame: six months
measure: Target vessel revascularization (TVR) rate
timeFrame: 12 months
measure: Target vessel revascularization (TVR) rate
timeFrame: 24 months
measure: Target vessel revascularization (TVR) rate
timeFrame: 36 months
measure: Cardiac, non-cardiac and all death rates
timeFrame: pre-discharge, estim. <10 days
measure: Cardiac, non-cardiac and all death rates
timeFrame: 30 days
measure: Cardiac, non-cardiac and all death rates
timeFrame: six months
measure: Cardiac, non-cardiac and all death rates
timeFrame: 12 months
measure: Cardiac, non-cardiac and all death rates
timeFrame: 24 months
measure: Cardiac, non-cardiac and all death rates
timeFrame: 36 months
measure: Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
timeFrame: pre-discharge, estim. <10 days
measure: Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
timeFrame: 30 days
measure: Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
timeFrame: six months
measure: Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
timeFrame: 12 months
measure: Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
timeFrame: 24 months
measure: Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)
timeFrame: 36 months
measure: Stent thrombosis rate (by ARC definition)
timeFrame: pre-discharge, estim. <10 days
measure: Stent thrombosis rate (by ARC definition)
timeFrame: 30 days
measure: Stent thrombosis rate (by ARC definition)
timeFrame: six months
measure: Stent thrombosis rate (by ARC definition)
timeFrame: 12 months
measure: Stent thrombosis rate (by ARC definition)
timeFrame: 24 months
measure: Stent thrombosis rate (by ARC definition)
timeFrame: 36 months
measure: Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
timeFrame: pre-discharge, estim. <10 days
measure: Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
timeFrame: 30 days
measure: Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
timeFrame: six months
measure: Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
timeFrame: 12 months
measure: Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
timeFrame: 24 months
measure: Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)
timeFrame: 36 months
measure: Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
timeFrame: pre-discharge, estim. <10 days
measure: Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
timeFrame: 30 days
measure: Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
timeFrame: six months
measure: Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
timeFrame: 12 months
measure: Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
timeFrame: 24 months
measure: Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)
timeFrame: 36 months
measure: Change in Quality of Life
timeFrame: six months
measure: Change in Quality of Life
timeFrame: 12 months
measure: Change in Quality of Life
timeFrame: 24 months
measure: Change in Quality of Life
timeFrame: 36 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc de Lyon
city: Montpellier
country: France
facility: Clinique du Millénaire, Montpellier
city: Montpellier
country: France
facility: CHU Montpellier, Hôpital Arnaud de Villeneuve
city: Nantes
country: France
facility: CHU de Nantes, Hopital Laennec
city: Rouen
country: France
facility: Clinique Saint Hilaire, Rouen
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Giessen
country: Germany
facility: University Giessen
city: Reutlingen
country: Germany
facility: Klinikum Am Steinenberg
city: Rostock
country: Germany
facility: Universitaetsklinikum Rostock
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
Study officials:
affiliation: University Giessen, Germany
name: Christian W. Hamm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamm CW, Dorr O, Woehrle J, Krackhardt F, Ince H, Zeus T, Berland J, Piot C, Roubille F, Schult I, Allocco DJ, Nef H. A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis. EuroIntervention. 2020 Jul 17;16(4):e328-e334. doi: 10.4244/EIJ-D-19-00051.