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The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser atherectomy and PTA | Experimental | laser, then balloon angioplasty |
|
| Balloon angioplasty | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turbo Elite Laser and Turbo Tandem Laser Guide Catheters | Device | application of laser energy to remove blockage followed by standard balloon angioplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Target Lesion Revascularization (TLR) | Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up. | 6 months |
| Freedom From Major Adverse Events (MAE) | Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days). | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric J Dippel, MD | Genesis Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's East | Birmingham | Alabama | 35235 | United States | ||
| Thomas Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25499305 | Derived | Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, Mena-Hurtado C, Beasley R, Soukas P, Colon-Hernandez PJ, Stark MA, Walker C; EXCITE ISR Investigators. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):92-101. doi: 10.1016/j.jcin.2014.09.009. Epub 2014 Dec 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser Atherectomy and PTA | laser, then balloon angioplasty Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty |
| FG001 | Balloon Angioplasty |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Balloon angioplasty | Procedure | standard balloon catheters for PTA |
|
| Fairhope |
| Alabama |
| 36533 |
| United States |
| St. Vincent Heart Clinic Arkansas | Little Rock | Arkansas | 72205 | United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| UC-Davis Medical Centers | Sacramento | California | 95817 | United States |
| Yale - New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| The Cardiac and Vascular Institute | Gainesville | Florida | 32605 | United States |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Mount Sinai Medical Center | Miami | Florida | 33140 | United States |
| St. John's Hospital | Springfield | Illinois | 62874 | United States |
| Community Hospital | Munster | Indiana | 46321 | United States |
| Genesis Health System | Davenport | Iowa | 52803 | United States |
| Cardiovascular Consultants | Bossier City | Louisiana | 71111 | United States |
| Regional Medical center of Acadiana | Lafayette | Louisiana | 70506 | United States |
| Opelousas General Hospital | Opelousas | Louisiana | 70570 | United States |
| Steward - St. Elizabeth's | Boston | Massachusetts | 02135 | United States |
| St. John's - Providence Hospital | Southfield | Michigan | 48075 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | United States |
| Deborah Heart and Lung | Browns Mills | New Jersey | 08015 | United States |
| New York University | New York | New York | 10016 | United States |
| Coastal Surgery Specialists | Wilmington | North Carolina | 284001 | United States |
| Bryn Mawr | Bryn Mawr | Pennsylvania | 19010 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02904 | United States |
| Wellmont Holston Valley Medical | Kingsport | Tennessee | 37660 | United States |
| Presbyterian Hospital of Dallas | Dallas | Texas | 75230 | United States |
| El Paso Cardiac and Endovascular Center | El Paso | Texas | 79902 | United States |
| Tyler Cardiac and Endovascular Center | Tyler | Texas | 75701 | United States |
| Providence Health Center | Waco | Texas | 76712 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Wheaton Franciscan Healthcare - All Saints Hospital | Milwaukee | Wisconsin | 53212 | United States |
| St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Transcatheter Medical Inc. | San Juan | 00926 | Puerto Rico |
Balloon angioplasty: standard balloon catheters for PTA |
| 30 Day Follow-up |
|
| 6 Month Follow-up |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser Atherectomy and PTA | laser, then balloon angioplasty Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty |
| BG001 | Balloon Angioplasty | Balloon angioplasty: standard balloon catheters for PTA |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Freedom From Target Lesion Revascularization (TLR) | Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up. | The number of participants analyzed for this endpoint does not match with the Participant Flow 6 Month Follow-up population. A subject may not complete a 6 Month Follow-up due to missing the visit, being lost to follow-up, etc., but if they had a TLR prior to this time point, they would still be included in this outcome analysis. | Posted | Number | # of participants free from TLR | 6 months |
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| Primary | Freedom From Major Adverse Events (MAE) | Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days). | The number of participants analyzed for this endpoint does not match with the Participant Flow 30 Day Follow-up population. If a subject did not complete a 30 Day Follow-up due to missing the visit or lost to follow-up, but had an MAE prior to this time point, they would still be included in this outcome analysis. | Posted | Number | # of participants free from MAE | 30 days |
|
|
Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
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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 | Laser Atherectomy and PTA | laser, then balloon angioplasty Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty | 117 | 170 | 88 | 170 | ||
| EG001 | Balloon Angioplasty | Balloon angioplasty: standard balloon catheters for PTA | 56 | 82 | 34 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection SAEs | Infections and infestations | Systematic Assessment |
| ||
| Cardiac SAEs | Cardiac disorders | Systematic Assessment |
| ||
| Other SAEs | General disorders | Systematic Assessment |
| ||
| Gastrointestinal SAEs | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neurological SAEs | Nervous system disorders | Systematic Assessment |
| ||
| Blood related disorder SAEs | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Vascular SAEs | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Other AEs | General disorders | Systematic Assessment |
| ||
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neurological | Nervous system disorders | Systematic Assessment |
| ||
| Blood related disorders | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Vascular | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Johnson, VP of Regulatory & Medical Affairs | Spectranetics | (719) 447-2000 | amanda.johnson@spnc.com |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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