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| ID | Type | Description | Link |
|---|---|---|---|
| FRUS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | renal artery stenting |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formula Balloon-Expandable Stent | Device | renal artery stenting |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency of the Treated Renal Artery | Based on ultrasound images assessed by core lab. | 9 Months |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bersin, MD | Swedish Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Munroe Regional Medical Center | Ocala | Florida | 34471 | United States | ||
| Orlando Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22581488 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Formula™ Balloon-Expandable Renal Stent | renal artery stenting |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 |
| Orlando |
| Florida |
| 32806 |
| United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| Wake Med Raleigh Campus | Raleigh | North Carolina | 27610 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Pinnacle Health at Harrisburg | Harrisburg | Pennsylvania | 17110 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Formula™ Balloon-Expandable Renal Stent | renal artery stenting |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Hypertension | Pre-hypertension: Systolic 120-139 mmHg, Diastolic 80-89 mmHg Stage 1: Systolic 140-159 mmHg, Diastolic 90-99 mmHg Stage 2: Systolic >160 mmHg, Diastolic > 100 mmHg If systolic and diastolic pressures were in different categories, the higher category was chosen. | Number | Participants |
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| Renal Insufficiency | Renal Insufficiency was defined by the physician, based on the patient's medical history. | Number | Participants |
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| Congestive Heart Failure | Number | Participants |
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| Serum Creatinine | Mean | Standard Deviation | mg/dl |
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| Estimated Glomerular Filtration Rate | Mean | Standard Deviation | ml/min |
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| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Number of Antihypertensive Medications per Patient | Mean | Standard Deviation | Antihypertensive Medications |
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| Percent Stenosis at Baseline | Baseline stenosis was determined by angiography. | Mean | Standard Deviation | Percent |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Primary Patency of the Treated Renal Artery | Based on ultrasound images assessed by core lab. | Posted | Number | Lesions | 9 Months | Lesions | Participants |
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| Secondary | 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. | 1 participant withdrew and 1 participant was lost to follow-up prior to 30 days. | Posted | Number | Participants | 30 Days |
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| Secondary | 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. | 3 participants withdrew, 4 died, and 1 was lost to follow-up prior to 300 days. | Posted | Number | Participants | 9 Months |
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| Secondary | Technical Success | Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure. | Posted | Number | Percentage of Participants | Prior to Discharge |
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| Secondary | Acute Procedural Success | < 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge. | 1 participant did not have core lab assessment for stenosis. | Posted | Number | Percentage of Participants | Prior to Discharge |
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| Secondary | 30-day Clinical Success | < 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days. | 1 participant was lost to follow-up, 1 participant withdrew, 1 participant did not have core lab assessment. | Posted | Number | Percentage of Participants | 30 Days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Formula™ Balloon-Expandable Renal Stent | renal artery stenting | 0 | 100 | 11 | 99 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmias (30 days to 9 months) | Cardiac disorders | 1 participant withdrew, 1 participant was lost to follow-up who experienced adverse events but were not reported here due to < 5% |
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| Cardiac Ischemia (30 days to 9 months) | Cardiac disorders | 1 participant withdrew, 1 participant was lost to follow-up who experienced adverse events but was not reported here due to < 5% |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Snyder, PhD | Cook Incorporated | 765-463-7537 | ssnyder@medinst.com |
| ID | Term |
|---|---|
| D012078 | Renal Artery Obstruction |
| D006973 | Hypertension |
| D006978 | Hypertension, Renovascular |
| D007674 | Kidney Diseases |
| D051437 | Renal Insufficiency |
| D050197 | Atherosclerosis |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006977 | Hypertension, Renal |
| D001161 | Arteriosclerosis |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Clinically-driven Target Lesion Revascularization |
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| Clinical Events Committee (CEC) Adjudicated Death |
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| CEC Adjudicated Significant Embolic Events |
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| Clinical Events Committee Adjudicated Q-wave MI |
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| Title | Denominators | Categories |
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