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

Hemoteq

Status

Completed

Conditions

Coronary Artery Disease

Coronary Atherosclerosis

Coronary Restenosis

Coronary Arteriosclerosis

Treatments

Device: Agent Paclitaxel-coated balloon

Device: SeQuent® Please Paclitaxel-coated Balloon

Study type

Interventional

Funder types

Industry

Identifiers

NCT02151812

HTQ002-Agent-ISR

CIV-13-11-011728 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

123 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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