Drug Eluting Balloon for Prevention of Constrictive Remodeling

Study Overview
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Brief Summary
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Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in diffuse small vessel disease especially of diabetic patients. High restenosis rates after balloon only procedures in small vessels occur due to negative constrictive vessel remodeling if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA) using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive remodelling process will be measured by optical coherence tomography (OCT) at 9 months median F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.

Official Title
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Drug Coated Balloon (DCB) for the Prevention of Constrictive Remodeling and Restenosis in Small Vessel Coronary Disease

Conditions
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Coronary Disease, Diabetes Mellitus

Intervention / Treatment
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* Device: Paclitaxel coated balloon catheter
* Device: uncoated balloon catheter sprinter legend


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least one target lesion with a stenosis severity ≥ 50% in one coronary segment with a diameter ≤ 2.5 mm age > 18 years weight > 45 kg patient suitable for balloon dilatation and not suitable for elective implantation of a drug eluting stent insulin-dependent or non-insulin-dependent diabetes mellitus length of lesion ≥ 15 mm Exclusion Criteria: Life expectancy < 12 months In-Stent restenosis planned coronary bypass or heart valve OP ST elevation myocardial infarction within the last 72 hours cardiogenic shock renal impairment or liver dysfunction (creatinine > 2.0 mg/dl, AST/ALT > 3x of normal value incompliance pregnant or breastfeeding women or women who like to be pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paclitaxel coated balloon catheter<br>Paclitaxel coated balloon catheter IN.PACT Falcon | Device: Paclitaxel coated balloon catheter<br>* Dilatation of the target lesion<br>* Other names: IN.PACT Falcon;|
| Active Comparator: uncoated balloon catheter<br>uncoated balloon catheter sprinter legend | Device: uncoated balloon catheter sprinter legend<br>* Dilatation of the target lesion<br>* Other names: sprinter legend;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE-rate | combined end-point: death, myocardial infarction and revascularisation of the target lesion | 12 months after initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT-measurement | each symptomatic patient will be examined using optical coherence tomography to detect, if the symptoms are caused by a narrowing at the target lesion | during follow-up, after 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting balloon, constrictive remodeling