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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00132743 |
The purpose of this study is to compare the effectiveness of aortic stent surgery versus exercise therapy in individuals with aortoiliac insufficiency.
Condition | Intervention | Phase |
---|---|---|
Cardiovascular Diseases Peripheral Vascular Diseases Atherosclerosis |
Device: Stent Behavioral: Supervised Exercise Therapy Drug: Cilostazol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) |
Estimated Enrollment: | 252 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Optimal Medical Care
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Drug: Cilostazol
Cilostazol, 100 mg twice a day
|
2: Active Comparator
Optimal Medical Care and Supervised Exercise
|
Behavioral: Supervised Exercise Therapy
Supervised exercise therapy, three times per week
Drug: Cilostazol
Cilostazol, 100 mg twice a day
|
3: Active Comparator
Optimal Medical Care and Stent
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Device: Stent
Stent
Drug: Cilostazol
Cilostazol, 100 mg twice a day
|
4: Active Comparator
Optimal Medical Care, Supervised Exercise, and Stent
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Device: Stent
Stent
Behavioral: Supervised Exercise Therapy
Supervised exercise therapy, three times per week
Drug: Cilostazol
Cilostazol, 100 mg twice a day
|
BACKGROUND:
Peripheral arterial disease (PAD) is a major source of morbidity and mortality, particularly in older individuals. Despite its high prevalence, clinicians often fail to diagnose PAD, particularly in patients who do not have classic claudication symptoms. Even in those individuals with documented PAD, cardiac risk factors are not often aggressively treated, and only a minority of patients receive pharmacologic therapy with cilostazol. Although there is a growing body of literature demonstrating the value of exercise rehabilitation in individuals with peripheral vascular disease and claudication, exercise rehabilitation is not often prescribed as supervised exercise rehabilitation for claudication, is not reimbursed by Medicare, and is rarely covered by private insurance. Therefore, few individuals with PAD and intermittent claudication have access to supervised exercise rehabilitation.
The use of surgical intervention and stent placement to improve blood flow in patients who do not have ischemic pain at rest or limb-threatening ischemia (Fontaine class III or IV) remains controversial. There is data suggesting that patients with intermittent claudication who have had revascularization with stents have improved exercise capacity and walking times. However, the patients in the various studies often differ substantially in their clinical characteristics, and a variety of techniques were employed, including balloon angioplasty and stents, which makes it difficult to come to a definitive conclusion about the relative efficacy of stenting to improve functional performance. Additionally, to our knowledge, the combination of stent revascularization with supervised exercise rehabilitation has not been studied.
DESIGN NARRATIVE:
The broad objective of the study is to optimize physical functioning, increase activity levels, and reduce cardiovascular disease risk in older individuals with PAD. The specific aim of the trial is to test the primary hypothesis that aortoiliac stenting/pharmacotherapy improves maximum walking duration (MWD) better than supervised exercise rehabilitation/exercise maintenance/pharmacotherapy for those with aortoiliac artery obstruction at 6 months. Other aims are to compare these two treatment groups with two other treatment groups, optimal medical care/pharmacotherapy and combined stent plus supervised exercise rehabilitation, at 6 months, and to compare all 4 groups with regard to the following variables: MWD change score at 18 months, changes in free-living daily activity levels, patient-perceived quality of life (QoL), and cost-effectiveness. The study also will perform exploratory analyses of demographic and biochemical risk factors for atherosclerosis, including body mass index (BMI), blood pressure, lipid profile, hemoglobin Alc (HgbAlc), fibrinogen, and C-reactive protein. An estimated 252 patients (at up to 30 study sites) with aortoiliac insufficiency and intermittent claudication will be randomly divided into four groups: optimal medical care/pharmacotherapy, supervised exercise rehabilitation/maintenance/pharmacotherapy, stent/pharmacotherapy, and stent/supervised exercise rehabilitation/pharmacotherapy. Recruitment will be performed over 28 months and patients will be followed for 18 months; the total study duration will be 5 years.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Positive noninvasive evaluation for significant aortoiliac PAD on the most symptomatic side(s) (bilaterally if symptoms are equal):
Vascular Noninvasive Physiologic Tests: Ankle-brachial index less than or equal to 0.9 (or abnormal ankle PVR waveform at ankle if arteries are incompressible*) with resting thigh-brachial index (thigh-BI) less than 1.1, and common femoral artery Doppler systolic acceleration time greater than 140 msec [these tests may be ordered for study screening].
Note: MRA/CTA, and contrast arteriogram images images must be submitted to the Clinical Coordinating Center and Doppler waveform tracings to the Noninvasive Test Committee for over read pre- or post-randomization
Exclusion Criteria:
Subject meets the following exclusions based upon modified American College of Sports Medicine criteria for exercise training:
i. Ambulation limited by co-morbid condition other than claudication, for example:1. severe coronary artery disease; 2. angina pectoris; 3. chronic lung disease;4. neurological disorder such as hemiparesis;5. arthritis, or other musculoskeletal conditions including amputation ii. Poorly-controlled hypertension (SBP greater than 180 mm Hg) iii.Poorly-controlled diabetes mellitus iv. Other active significant medical problems such as cancer, known chronic renal disease (serum creatinine greater than 2.0 mg/dl within 60 days or renal replacement therapy), known chronic liver disease or anemia, active substance abuse, or known history of dementia
Contact: Joselyn Cerezo, MD | 401-444-1739 | jcerezo@lifespan.org |
Contact: Niki Oldenburg, Phd | 612-625-8781 | oldenburg@epi.umn.edu |
Principal Investigator: | Don Cutlip, MD | Brigham and Women's Hospital |
Principal Investigator: | Timothy Murphy, MD | Rhode Island Hospital |
Responsible Party: | Rhode Island Hospital ( Timothy Murphy, MD ) |
Study ID Numbers: | 224, U01 HL77221, U01 HL81656 |
Study First Received: | August 19, 2005 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00132743 |
Health Authority: | United States: Food and Drug Administration |
Arterial Occlusive Diseases Atherosclerosis Cilostazol |
Peripheral Vascular Diseases Vascular Diseases Arteriosclerosis |
Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Anti-Asthmatic Agents Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Protective Agents Neuroprotective Agents |
Pharmacologic Actions Fibrin Modulating Agents Phosphodiesterase Inhibitors Autonomic Agents Therapeutic Uses Platelet Aggregation Inhibitors Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |