Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Atherosclerosis, Coronary Restenosis
Conditions
Brief summary
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.
Interventions
DEVICEAgent Paclitaxel-coated balloon
After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.
DEVICESeQuent® 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.
Sponsors
Hemoteq AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| in-stent late lumen loss | six months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical procedural success rate | within 24 hours of index procedure | Technical success with no composite of all death and MI noted within 24 hours of the index procedure. |
| In-stent percent diameter stenosis | 6 months post-index procedure | In-stent percent diameter reduction measured within the borders of the stent |
| In-segment percent diameter stenosis | 6 months post-index procedure | In-segment percent diameter reduction measured in the stented segment plus 5mm on either side. |
| In-stent binary restenosis rate | 6 months post-index procedure | In-stent binary restenosis is defined as ≥50% luminal narrowing within the borders of the stent observed at follow-up QCA. |
| In-segment binary restenosis rate | 6 months post-index procedure | In-segment binary restenosis is defined as ≥50% luminal narrowing in the stented segment plus 5mm on either side observed at follow-up QCA. |
| In-segment late lumen loss | 6 months post-index procedure | In-segment late lumen loss is the in-segment minimal lumen diameter (MLD) post index procedure minus the in-segment MLD at 6 months follow-up as determined by QCA. |
| In-stent minimal lumen diameter (MLD) | 6 months post-index procedure | In-stent MLD is measured within the borders of the stent. |
| In-segment minimal lumen diameter (MLD) | 6 months post-index procedure | In-segment MLD is measured in the stented segment plus 5mm on either side. |
| technical success rate | during index procedure, less 1 hour | The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30 percent |
| Target vessel revascularization (TVR) rate | pre-discharge, estim. <10 days | TVR rate during index in-hospital stay |
| Cardiac, non-cardiac and all death rates | pre-discharge, estim. <10 days | rates during index in-hospital stay |
| Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI) | pre-discharge, estim. <10 days | rates during index in-hospital stay |
| Stent thrombosis rate (by ARC definition) | pre-discharge, estim. <10 days | rates during index in-hospital stay |
| Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR) | pre-discharge, estim. <10 days | rates during index in-hospital stay |
| Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR) | pre-discharge, estim. <10 days | rates during index in-hospital stay |
| Change in Quality of Life | six months | Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline |
| Target lesion revascularization (TLR) rate | pre-discharge, estim. <10 days | TLR rate during index in-hospital stay |
Countries
France, Germany
Outcome results
None listed