REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis.

Conditions
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Renal Artery Stenosis

Intervention / Treatment
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* Device: Formula Balloon-Expandable Stent


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: renal artery stenosis appropriate size and location of the lesion suboptimal angioplasty Key Exclusion Criteria: less than 18 years old failure or inability to give informed consent simultaneously participating in another drug or device study

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>renal artery stenting | Device: Formula Balloon-Expandable Stent<br>* renal artery stenting<br>* Other names: renal artery revascularization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency of the Treated Renal Artery | Based on ultrasound images assessed by core lab. | 9 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With 30-day Major Adverse Events | Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events. | 30 Days | 
| Number of Participants With 9-month Major Adverse Events | Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events. | 9 Months | 
| Technical Success | Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure. | Prior to Discharge | 
| Acute Procedural Success | < 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge. | Prior to Discharge | 
| 30-day Clinical Success | < 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days. | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal artery stenosis, hypertension, renovascular, renal artery blockage, renal artery disease, renal arteries, angioplasty renal artery, renal artery stent, renal artery doppler, renovascular hypertension, kidney stenosis, renal artery, stent, stenting, kidney disease, renal failure, atherosclerosis, arterial hypertension, stenosis