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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00631540
First received: February 28, 2008
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Renal Artery Stenosis
 Device: Formula Balloon-Expandable Stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Primary Patency of the Treated Renal Artery [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    Based on ultrasound images assessed by core lab.


Secondary Outcome Measures:
  • Number of Participants With 30-day Major Adverse Events [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.

  • Number of Participants With 9-month Major Adverse Events [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
    Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.

  • Technical Success [ Time Frame: Prior to Discharge ] [ Designated as safety issue: No ]
    Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.

  • Acute Procedural Success [ Time Frame: Prior to Discharge ] [ Designated as safety issue: No ]
    < 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.

  • 30-day Clinical Success [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    < 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.


Enrollment: 100
Study Start Date: February 2008
Study Completion Date: May 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
renal artery stenting
 Device: Formula Balloon-Expandable Stent
renal artery stenting
Other Name: renal artery revascularization

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Robert Bersin, MD Swedish Medical Center
  More Information

Additional Information:
Click here for more information including overall description of study, study device, investigative sites, and information for patients.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00631540     History of Changes
Other Study ID Numbers: 06-581, FRUS
Study First Received: February 28, 2008
Results First Received: February 11, 2011
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
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

ClinicalTrials.gov processed this record on May 23, 2013