Claudication (Finding), Peripheral Arterial Disease
Conditions
Keywords
leg pain, claudication
Brief summary
Twenty patients will be recruited to CLEAR. Ten will be randomized to the treatment arm (Cilostazol) and tenwill be randomized to the control group. Patients randomized to the treatment arm will receive Cilostazol for 90 days. The primary purpose of this study is to collect quality of life data on patients undergoing peripheral revascularization in order to determine the sample size required to adequately power a trial of Cilostazol versus usual care without Cilostazol and its effect on quality of life.
Detailed description
Cilostazol is the only medication approved for use in peripheral arterial disease (PAD) patients to reduce claudication symptoms. Contemporary data has demonstrated that Cilostazol improves patency after endovascular interventions in multiple randomized trials and retrospective studies done in Japan in both critical limb ischemia and claudication patients. However, Cilostazol use after peripheral revascularization has been sporadic and there has been no research to estimate patient quality of life with use of Cilostazol after open or endovascular lower extremity revascularization. This is a prospective investigator initiated single-center open-label, non-placebo controlled pilot study. Eligible patients would be randomized to either the Cilostazol treatment or the non-Cilostazol treatment groups using a closed envelope randomization technique. Twenty patients will be recruited and randomized; Ten to the treatment group and tento the control group. The primary purpose of this pilot study is to collect quality of life data on patients undergoing peripheral revascularization in order to determine the sample size required for adequate powered trial of Cilostazol versus usual care without Cilostazol and its effect on Quality of Life.
Interventions
DRUGCilostazol
100 mg twice daily for 90 days
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 35 years of age * Atherosclerotic peripheral arterial disease * Able to provide informed consent * Lower extremity open or endovascular revascularization.
Exclusion criteria
* Known CHF (class III/IV) * Allergic reaction to phosphodiasterase inhibitors * Intracranial bleeding within 3 months or active bleeding peptic ulcer disease * Traumatic vascular injuries requiring revascularization * Pregnant or breast feeding women or women who plan to get pregnant over the study period * Planned ipsilateral major amputation within 30 days of index procedure * Moderate to severe hepatic impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months | Baseline and 3 months | The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from slow walk to running. Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point. With the EACH-Q higher scores are better. |
| Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks | Baseline and 6 weeks. | The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression. Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions. The EQ5D sum score is a composite sum of the individual dimension scores. Values of the total score can range from 5 to 25 with higher scores indicating a worse health state. Separate change scores are estimated at each follow-up time point. |
| Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months | Baseline and 3 months | The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. . The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression. Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions. The EQ5D sum score is a composite sum of the individual dimension scores. Values of the total score can range from 5 to 25 with higher scores indicating a worse health state. Separate change scores are estimated at each follow-up time point. |
| Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. | Baseline and Six Weeks | The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled best imaginable health state and worst imaginable health state with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point. Higher numbers are better. |
| Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. | Baseline and 3 months | The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled best imaginable health state and worst imaginable health state with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point. Higher numbers are better. |
| Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks | Baseline and Six Weeks | The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from slow walk to running. Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point. With the EACH-Q higher scores are better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention. | 13 days to 259 days | Graft patency was determined by duplex scan as opened or occluded. Follow-up duplex testing ranged from 13 days to 259 days. Number of patency failures (i.e., graft occlusions) are shown below by treatment arm. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patients Who Had Amputations Following Initial Procedure. | 90 days | Patients who went on to have amputations following initial procedure |
| Number of Participants Who Had a Stroke | 90 days | Secondary outcome measure - patients who had a stroke during the 90 day follow up period. |
| Claudication Symptoms and Rest Pain. | 90 days | Secondary outcome measures including claudication symptoms and rest pain. |
| Number of Participants Affected by Death | 90 days | Number of Participants affected by Death was reported |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cilostazol Administer Cilostazol100 mg twice daily for 90 days.
Cilostazol: 100 mg twice daily for 90 days | 10 |
| Control No Cilostazol | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient did not complete forms correctly | 1 | 0 |
Baseline characteristics
| Characteristic | Cilostazol | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Continuous | 63.60 years | 63.11 years | 63.37 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 1 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 3 / 10 | 3 / 9 |
Outcome results
Primary
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months
The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. . The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression. Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions. The EQ5D sum score is a composite sum of the individual dimension scores. Values of the total score can range from 5 to 25 with higher scores indicating a worse health state. Separate change scores are estimated at each follow-up time point.
Time frame: Baseline and 3 months
Population: Only patients with data collected at each pair of time points are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cilostazol | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months | Baseline | 14.50 score on a scale | Standard Deviation 4.07 |
| Cilostazol | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months | Three Months | 13.75 score on a scale | Standard Deviation 4.62 |
| Cilostazol | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months | 3 Month Change Score | 0.75 score on a scale | Standard Deviation 3.77 |
| Control | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months | Baseline | 16.17 score on a scale | Standard Deviation 2.71 |
| Control | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months | Three Months | 12.50 score on a scale | Standard Deviation 3.21 |
| Control | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months | 3 Month Change Score | 3.67 score on a scale | Standard Deviation 3.5 |
Comparison: Null hypothesis: three-month change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over three months (two-sided test).p-value: 0.17t-test, 2 sided
Primary
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks
The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression. Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions. The EQ5D sum score is a composite sum of the individual dimension scores. Values of the total score can range from 5 to 25 with higher scores indicating a worse health state. Separate change scores are estimated at each follow-up time point.
Time frame: Baseline and 6 weeks.
Population: Only patients with data collected at each pair of time points are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cilostazol | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks | Baseline | 14.00 score on a scale | Standard Deviation 4 |
| Cilostazol | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks | Six Weeks | 12.89 score on a scale | Standard Deviation 3.33 |
| Cilostazol | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks | Six Week Change Score | 1.11 score on a scale | Standard Deviation 3.89 |
| Control | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks | Baseline | 15.57 score on a scale | Standard Deviation 2.94 |
| Control | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks | Six Weeks | 12.14 score on a scale | Standard Deviation 4.53 |
| Control | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks | Six Week Change Score | 3.43 score on a scale | Standard Deviation 3.95 |
Comparison: Null hypothesis: six-week change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over initial six weeks (two-sided test).p-value: 0.26t-test, 2 sided
Primary
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months.
The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled best imaginable health state and worst imaginable health state with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point. Higher numbers are better.
Time frame: Baseline and 3 months
Population: Only patients with data collected at each pair of time points are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cilostazol | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. | Baseline | 57.50 score on a scale | Standard Deviation 13.89 |
| Cilostazol | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. | Three Months | 47.50 score on a scale | Standard Deviation 21.88 |
| Cilostazol | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. | 3 Month Change Score | -10.00 score on a scale | Standard Deviation 14.14 |
| Control | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. | Baseline | 41.67 score on a scale | Standard Deviation 24.22 |
| Control | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. | Three Months | 65.83 score on a scale | Standard Deviation 28 |
| Control | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months. | 3 Month Change Score | 24.17 score on a scale | Standard Deviation 29.73 |
Comparison: Null hypothesis: three-month change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over three months (two-sided test).p-value: 0.014t-test, 2 sided
Primary
Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks.
The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled best imaginable health state and worst imaginable health state with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point. Higher numbers are better.
Time frame: Baseline and Six Weeks
Population: Only patients with data collected at each pair of time points are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cilostazol | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. | Baseline | 61.67 score on a scale | Standard Deviation 17.32 |
| Cilostazol | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. | Six Weeks | 60.00 score on a scale | Standard Deviation 24.37 |
| Cilostazol | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. | 6 Week Change Score | -1.67 score on a scale | Standard Deviation 21.94 |
| Control | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. | Baseline | 42.86 score on a scale | Standard Deviation 22.33 |
| Control | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. | Six Weeks | 71.43 score on a scale | Standard Deviation 23.4 |
| Control | Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks. | 6 Week Change Score | 28.57 score on a scale | Standard Deviation 27.04 |
Comparison: Null hypothesis: six-week change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over initial six weeks (two-sided test).p-value: 0.027t-test, 2 sided
Primary
Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months
The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from slow walk to running. Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point. With the EACH-Q higher scores are better.
Time frame: Baseline and 3 months
Population: Only patients with data collected at each pair of time points are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cilostazol | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months | Baseline | 13.38 score on a scale | Standard Deviation 9.15 |
| Cilostazol | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months | Three Months | 15.25 score on a scale | Standard Deviation 18.91 |
| Cilostazol | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months | 3 Month Change Score | 1.88 score on a scale | Standard Deviation 17.01 |
| Control | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months | Baseline | 15.50 score on a scale | Standard Deviation 11.64 |
| Control | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months | Three Months | 13.00 score on a scale | Standard Deviation 10.94 |
| Control | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months | 3 Month Change Score | -2.50 score on a scale | Standard Deviation 12.83 |
Comparison: Null hypothesis: three-month change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over three months (two-sided test).p-value: 0.61t-test, 2 sided
Primary
Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks
The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from slow walk to running. Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point. With the EACH-Q higher scores are better.
Time frame: Baseline and Six Weeks
Population: Only patients with data collected at each pair of time points are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cilostazol | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks | Baseline | 17.11 score on a scale | Standard Deviation 8.82 |
| Cilostazol | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks | Six Weeks | 13.78 score on a scale | Standard Deviation 9.2 |
| Cilostazol | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks | Change Score | -3.33 score on a scale | Standard Deviation 12.04 |
| Control | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks | Baseline | 16.43 score on a scale | Standard Deviation 10.91 |
| Control | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks | Six Weeks | 11.71 score on a scale | Standard Deviation 7.91 |
| Control | Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks | Change Score | -4.71 score on a scale | Standard Deviation 11.51 |
Comparison: Null hypothesis: six-week change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over initial six weeks (two-sided test).p-value: 0.82t-test, 2 sided
Secondary
Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.
Graft patency was determined by duplex scan as opened or occluded. Follow-up duplex testing ranged from 13 days to 259 days. Number of patency failures (i.e., graft occlusions) are shown below by treatment arm.
Time frame: 13 days to 259 days
Population: One patient had no scans to determine graft patency.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cilostazol | Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention. | 3 Participants |
| Control | Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention. | 2 Participants |
Comparison: Null hypothesis: time to patency-failure (graft occlusion) is the same between treatment arms.~Alternate hypothesis: one arm differs from the other in durability of graft patency (two-sided test).p-value: 0.26Log Rank
Other Pre-specified
Claudication Symptoms and Rest Pain.
Secondary outcome measures including claudication symptoms and rest pain.
Time frame: 90 days
Population: No data collected due to early termination of study.
Other Pre-specified
Number of Participants Affected by Death
Number of Participants affected by Death was reported
Time frame: 90 days
Population: Overall survival
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cilostazol | Number of Participants Affected by Death | 0 Participants |
| Control | Number of Participants Affected by Death | 1 Participants |
Other Pre-specified
Number of Participants Who Had a Stroke
Secondary outcome measure - patients who had a stroke during the 90 day follow up period.
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cilostazol | Number of Participants Who Had a Stroke | 0 Participants |
| Control | Number of Participants Who Had a Stroke | 0 Participants |
Other Pre-specified
Patients Who Had Amputations Following Initial Procedure.
Patients who went on to have amputations following initial procedure
Time frame: 90 days
Population: Nineteen patients randomized to either Cilostazol or Control group who had lower extremity revascularization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cilostazol | Patients Who Had Amputations Following Initial Procedure. | 1 Participants |
| Control | Patients Who Had Amputations Following Initial Procedure. | 2 Participants |