Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)

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)

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.

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