NCT02151812 - Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR) | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

in-stent late lumen loss

In-stent late lumen loss (LLL) of the treated stented segment after PTCA using the Agent(TM) study device in comparison to the LLL after PTCA using the SeQuent(R) Please control device as measured by QCA at six months post-index procedure.

Time frame: six months

Secondary Outcomes

technical success rate

The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30 percent

Time frame: during index procedure, less 1 hour

clinical procedural success rate

Technical success with no composite of all death and MI noted within 24 hours of the index procedure.

Time frame: within 24 hours of index procedure

In-stent percent diameter stenosis

In-stent percent diameter reduction measured within the borders of the stent