Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)
NCT ID: NCT02151812
Last Updated: 2019-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2014-08-13
2019-10-28
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Agent Paclitaxel-coated balloon
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.
SeQuent Please Paclitaxel-coated balloon
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Hemoteq AG
INDUSTRY
Responsible Party
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Principal Investigators
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Christian W. Hamm, MD
Role: PRINCIPAL_INVESTIGATOR
University Giessen, Germany
Locations
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Centre Hospitalier Saint Joseph Saint Luc de Lyon
Lyon, , France
Clinique du Millénaire, Montpellier
Montpellier, , France
CHU Montpellier, Hôpital Arnaud de Villeneuve
Montpellier, , France
CHU de Nantes, Hopital Laennec
Nantes, , France
Clinique Saint Hilaire, Rouen
Rouen, , France
Kerckhoff-Klinik
Bad Nauheim, , Germany
Charité Universitaetsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
University Giessen
Giessen, , Germany
Klinikum Am Steinenberg
Reutlingen, , Germany
Universitaetsklinikum Rostock
Rostock, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Countries
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References
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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.
Other Identifiers
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CIV-13-11-011728
Identifier Type: OTHER
Identifier Source: secondary_id
HTQ002-Agent-ISR
Identifier Type: -
Identifier Source: org_study_id