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

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ClinicalTrials.gov Identifier: NCT00631540
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : May 19, 2011
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

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

Condition or disease Intervention/treatment Phase
Renal Artery Stenosis Device: Formula Balloon-Expandable Stent Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: 1
renal artery stenting
Device: Formula Balloon-Expandable Stent
renal artery stenting
Other Name: renal artery revascularization




Primary Outcome Measures :
  1. Primary Patency of the Treated Renal Artery [ Time Frame: 9 Months ]
    Based on ultrasound images assessed by core lab.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631540


Locations
United States, Florida
Munroe Regional Medical Center
Ocala, Florida, United States, 34471
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
United States, New York
Lenox Hill Hospital
New York, New York, United States, 10075
United States, North Carolina
Wake Med Raleigh Campus
Raleigh, North Carolina, United States, 27610
United States, Ohio
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
United States, Pennsylvania
Pinnacle Health at Harrisburg
Harrisburg, Pennsylvania, United States, 17110
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Robert Bersin, MD Swedish Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00631540     History of Changes
Other Study ID Numbers: 06-581
FRUS
First Posted: March 7, 2008    Key Record Dates
Results First Posted: May 19, 2011
Last Update Posted: December 16, 2013
Last Verified: November 2013

Keywords provided by Cook Group Incorporated:
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

Additional relevant MeSH terms:
Constriction, Pathologic
Renal Artery Obstruction
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases