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Completed

NCT Number: NCT00631540

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

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

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Key information

Conditions

Renal Artery Stenosis Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Constriction, Pathologic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Renal Hypertension, Renovascular Kidney Diseases Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Artery Obstruction Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Munroe Regional Medical Center, Ocala, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formula Balloon-Expandable Stent

Device

renal artery stenting

Other names: renal artery revascularization

Primary outcomes

  1. Primary Patency of the Treated Renal Artery

    Time frame: 9 Months

    Based on ultrasound images assessed by core lab.

Secondary outcomes

  1. Number of Participants With 30-day Major Adverse Events

    Time frame: 30 Days

    Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.

  2. Number of Participants With 9-month Major Adverse Events

    Time frame: 9 Months

    Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.

  3. Technical Success

    Time frame: Prior to Discharge

    Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.

  4. Acute Procedural Success

    Time frame: Prior to Discharge

    < 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.

  5. 30-day Clinical Success

    Time frame: 30 Days

    < 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Mar 7, 2008
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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