Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT02151812
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02151812
Study Brief:
Protocol Section:
NCT02151812