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

Primary Purpose

Renal Artery Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Formula Balloon-Expandable Stent
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Artery Stenosis focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Munroe Regional Medical Center
  • Orlando Regional Medical Center
  • Lenox Hill Hospital
  • Wake Med Raleigh Campus
  • Fairfield Medical Center
  • Pinnacle Health at Harrisburg
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

renal artery stenting

Outcomes

Primary Outcome Measures

Primary Patency of the Treated Renal Artery
Based on ultrasound images assessed by core lab.

Secondary Outcome Measures

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.
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.
Technical Success
Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.
Acute Procedural Success
< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.
30-day Clinical Success
< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.

Full Information

First Posted
February 28, 2008
Last Updated
November 21, 2013
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00631540
Brief Title
REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Stenosis
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
renal artery stenting
Intervention Type
Device
Intervention Name(s)
Formula Balloon-Expandable Stent
Other Intervention Name(s)
renal artery revascularization
Intervention Description
renal artery stenting
Primary Outcome Measure Information:
Title
Primary Patency of the Treated Renal Artery
Description
Based on ultrasound images assessed by core lab.
Time Frame
9 Months
Secondary Outcome Measure Information:
Title
Number of Participants With 30-day Major Adverse Events
Description
Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
Time Frame
30 Days
Title
Number of Participants With 9-month Major Adverse Events
Description
Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.
Time Frame
9 Months
Title
Technical Success
Description
Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.
Time Frame
Prior to Discharge
Title
Acute Procedural Success
Description
< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.
Time Frame
Prior to Discharge
Title
30-day Clinical Success
Description
< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bersin, MD
Organizational Affiliation
Swedish Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Wake Med Raleigh Campus
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
Pinnacle Health at Harrisburg
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22581488
Citation
Bersin RM, Ansel G, Rizzo A, Bob Smouse H, Sinha S, Sachar R, Dave R, Weinstock BS, Feldman R, Roubin GS. Nine-month results of the REFORM study: a prospective, single-arm, multicenter clinical study of the safety and effectiveness of the Formula balloon-expandable stent for treatment of renal artery stenosis. Catheter Cardiovasc Interv. 2013 Aug 1;82(2):266-73. doi: 10.1002/ccd.24481. Epub 2013 Mar 25.
Results Reference
derived

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

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