LEOPARD: Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
Sponsor
Endologix (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02407457
Collaborator
(none)
455
56
2
90.1
8.1
0.1
Study Details
Study Description
Brief Summary
The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. Imaging data will be evaluated by an independent core lab.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This trial is a prospective, randomized, multi-center trial, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The trial is designed to compare the anatomically stabilized AFX Endograft System to a reference group of proximally fixated EVAR devices. Patients will be randomized between the two groups.
Randomization will be 1:1. Each investigator will select one comparator device of their choice before enrolling the first patient. The study will sequentially evaluate non-inferiority and superiority hypotheses.
Up to 80 sites with experience in EVAR and up to 800 subjects will participate in this study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
455 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD
Actual Study Start Date
:
Mar 1, 2015
Actual Primary Completion Date
:
Oct 1, 2018
Anticipated Study Completion Date
:
Sep 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: AFX EVAR AAA Graft System Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. |
Device: AFX EVAR AAA Graft System
Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
|
| Active Comparator: FDA Approved EVAR AAA Graft Systems Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. |
Device: FDA Approved EVAR AAA Graft Systems
|
Outcome Measures
Primary Outcome Measures
- Number of Patients With Absence of Aneurysm Related Complications (ARC) [1 year]
ARC is a composite of the most relevant EVAR outcomes and includes: Peri-Operative Death (< 30 days) Rupture Conversion to OSR Endoleaks; post-operative Migration (≥ 10mm) Aneurysm Enlargement (≥ 5mm) Endograft Limb Occlusions Reinterventions for device- or aneurysm-related complications
Secondary Outcome Measures
- The Number of MAEs [At 30 days, 12 months, and annually up to five years]
Major Adverse Events
- The Number of Aneurysm Related Complications (ARC) [Post 12 Months up to Five Years]
ARC is a composite outcome
- The Number of Participants With Aneurysm Related Mortality [Up to Five Years]
Death related to the aneurysm
- Number of Endoleaks Classified by Type [Up to Five Years]
All Endoloeaks
- Loss of Neck Apposition as Measured by Length in mm [Up to Five Years]
Loss of Neck Apposition as measured by length in mm
- Number of AAA Related Secondary Procedures [Up to Five Years]
Number of AAA related secondary procedures
- Number of Device Integrity Events [Up to Five Years]
Number of device integrity events from device fractures and technical observations related to the stent graft
- Number of Adjunctive Procedures Necessitated During the Implant Procedure. [Up to Five Years]
Number of adjunctive procedures done during the implant procedure
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female at least 18 years old
-
Subjects with minimum of 2 year life expectancy
-
Subjects have signed the informed consent document for data release
-
Subjects with infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
Exclusion Criteria:
-
Currently participating in another study where primary endpoint has not been reached yet
-
Known allergy to any of the device components
-
Pregnant (females of childbearing potential only)
-
Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eliza Coffee Medical Center | Florence | Alabama | United States | 35630 |
| 2 | Huntsville Hospital | Huntsville | Alabama | United States | 35801 |
| 3 | Banner Good Samaritan Hospital | Phoenix | Arizona | United States | 85006 |
| 4 | Carondelet Heart and Vascular Institute | Tucson | Arizona | United States | 85745 |
| 5 | Central Arkansas Veteran's Healthcare System | Little Rock | Arkansas | United States | 72205 |
| 6 | Long Beach VA Hospital | Long Beach | California | United States | 90822 |
| 7 | Sacramento Vascular Sugeons | Sacramento | California | United States | 95816 |
| 8 | Kaiser - Santa Clara | Santa Clara | California | United States | 95051 |
| 9 | Penrose St. Francis Health | Colorado Springs | Colorado | United States | 80907 |
| 10 | Hartford Hospital | New Britain | Connecticut | United States | 61110 |
| 11 | Yale University | New Haven | Connecticut | United States | 48097 |
| 12 | Mayo Jacksonville | Jacksonville | Florida | United States | 32224 |
| 13 | Mount Sinai Medical Center | Miami Beach | Florida | United States | 33140 |
| 14 | Vascular Institute of Central Florida | Orlando | Florida | United States | 32803 |
| 15 | Sarasota Vascular Specialists | Sarasota | Florida | United States | 34232 |
| 16 | USF/Tampa VA | Tampa | Florida | United States | 33606 |
| 17 | Emory/Grady | Atlanta | Georgia | United States | 30303 |
| 18 | Navicent Health Medical Center | Macon | Georgia | United States | 31201 |
| 19 | Peachtree Vascular Specialists | Stockbridge | Georgia | United States | 30281 |
| 20 | Prairie Education & Research Cooperative | Springfield | Illinois | United States | 62701 |
| 21 | Cadence Physician Group | Winfield | Illinois | United States | 60190 |
| 22 | Parkview Research Center | Fort Wayne | Indiana | United States | 46845 |
| 23 | Franciscan - St. Francis Hospital | Indianapolis | Indiana | United States | 46237 |
| 24 | University of Iowa Healthcare | Iowa City | Iowa | United States | 52246 |
| 25 | The Iowa Clinic Cardiovascular Services | West Des Moines | Iowa | United States | 50266 |
| 26 | Surgical Care Associates | Louisville | Kentucky | United States | 40207 |
| 27 | Cardiovascular Research Foundation of Louisiana | Baton Rouge | Louisiana | United States | 70808 |
| 28 | Baton Rouge Vascular Specialty Center | Baton Rouge | Louisiana | United States | 70809 |
| 29 | VA Maryland Health Care System | Baltimore | Maryland | United States | 21201 |
| 30 | Peninsula Regional Medical Center | Salisbury | Maryland | United States | 21801 |
| 31 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 32 | St. Joseph Mercy Ann Arbor | Ypsilanti | Michigan | United States | 48197 |
| 33 | Hattiesburg Clinic | Hattiesburg | Mississippi | United States | 39402 |
| 34 | North MS Medical Center | Tupelo | Mississippi | United States | 38801 |
| 35 | University of Missouri | Columbia | Missouri | United States | 65212 |
| 36 | Kansas City Vascular | North Kansas City | Missouri | United States | 64116 |
| 37 | Saint Louis University | Saint Louis | Missouri | United States | 63124 |
| 38 | The Vascular Group | Albany | New York | United States | 12208 |
| 39 | VA Western New York Healthcare System | Buffalo | New York | United States | 14215 |
| 40 | Wake Forest | Winston-Salem | North Carolina | United States | 27157 |
| 41 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
| 42 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 43 | Innovation Center, Kettering Health Network | Kettering | Ohio | United States | 45429 |
| 44 | Neo Vascular (Lake West) | Willoughby | Ohio | United States | 44094 |
| 45 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 46 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 47 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 48 | North Central Heart | Sioux Falls | South Dakota | United States | 57108 |
| 49 | Cardiothoracic & Vascular Surgeons | Austin | Texas | United States | 78756 |
| 50 | University of Texas Health | Houston | Texas | United States | 77030 |
| 51 | University of Vermont Medical Center | Burlington | Vermont | United States | 05401 |
| 52 | Sentara Vascular Specialists | Norfolk | Virginia | United States | 23507 |
| 53 | Peacehealth Southwest Medical Center | Vancouver | Washington | United States | 98664 |
| 54 | University of Wisconsin | Madison | Wisconsin | United States | 53792 |
| 55 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 56 | Clement J. Zablocki VA Medical Center | Milwaukee | Wisconsin | United States | 53295 |
Sponsors and Collaborators
- Endologix
Investigators
- Principal Investigator: Christopher Kwolek, MD, Endologix
Study Documents (Full-Text)
More Information
Publications
- Brown LC, Greenhalgh RM, Thompson SG, Powell JT; EVAR Trial Participants. Does EVAR alter the rate of cardiovascular events in patients with abdominal aortic aneurysm considered unfit for open repair? Results from the randomised EVAR trial 2. Eur J Vasc Endovasc Surg. 2010 Apr;39(4):396-402. doi: 10.1016/j.ejvs.2010.01.002. Epub 2010 Jan 21.
- De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, van Sambeek MR, Balm R, Grobbee DE, Blankensteijn JD; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9. doi: 10.1056/NEJMoa0909499.
- Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8.
- Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sambeek MR, Balm R, Buskens E, Grobbee DE, Blankensteijn JD; Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004 Oct 14;351(16):1607-18.
- Stroupe KT, Lederle FA, Matsumura JS, Kyriakides TC, Jonk YC, Ge L, Freischlag JA; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Cost-effectiveness of open versus endovascular repair of abdominal aortic aneurysm in the OVER trial. J Vasc Surg. 2012 Oct;56(4):901-9.e2. doi: 10.1016/j.jvs.2012.01.086. Epub 2012 May 27.
- Volodos' NL, Karpovich IP, Shekhanin VE, Troian VI, Iakovenko LF. [A case of distant transfemoral endoprosthesis of the thoracic artery using a self-fixing synthetic prosthesis in traumatic aneurysm]. Grudn Khir. 1988 Nov-Dec;(6):84-6. Russian.
Responsible Party:
Endologix
ClinicalTrials.gov Identifier:
NCT02407457
Other Study ID Numbers:
- CP-0011
First Posted:
Apr 3, 2015
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | AFX EVAR AAA Graft System | FDA Approved EVAR AAA Graft Systems |
|---|---|---|
| Arm/Group Description | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
| Period Title: Baseline | ||
| STARTED | 235 | 220 |
| COMPLETED | 235 | 220 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Baseline | ||
| STARTED | 235 | 220 |
| COMPLETED | 229 | 213 |
| NOT COMPLETED | 6 | 7 |
| Period Title: Baseline | ||
| STARTED | 231 | 219 |
| COMPLETED | 211 | 194 |
| NOT COMPLETED | 20 | 25 |
| Period Title: Baseline | ||
| STARTED | 227 | 208 |
| COMPLETED | 194 | 180 |
| NOT COMPLETED | 33 | 28 |
| Period Title: Baseline | ||
| STARTED | 218 | 194 |
| COMPLETED | 184 | 159 |
| NOT COMPLETED | 34 | 35 |
| Period Title: Baseline | ||
| STARTED | 198 | 175 |
| COMPLETED | 156 | 137 |
| NOT COMPLETED | 42 | 38 |
| Period Title: Baseline | ||
| STARTED | 181 | 156 |
| COMPLETED | 100 | 95 |
| NOT COMPLETED | 81 | 61 |
| Period Title: Baseline | ||
| STARTED | 123 | 113 |
| COMPLETED | 31 | 36 |
| NOT COMPLETED | 92 | 77 |
Baseline Characteristics
| Arm/Group Title | AFX EVAR AAA Graft System | FDA Approved EVAR AAA Graft Systems | Total |
|---|---|---|---|
| Arm/Group Description | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems | Total of all reporting groups |
| Overall Participants | 235 | 220 | 455 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
72
(8)
|
72
(8)
|
72
(8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
23
9.8%
|
28
12.7%
|
51
11.2%
|
| Male |
212
90.2%
|
192
87.3%
|
404
88.8%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Caucasian |
225
95.7%
|
199
90.5%
|
424
93.2%
|
| Non-caucasian |
10
4.3%
|
21
9.5%
|
31
6.8%
|
| ASA Classification (Count of Participants) | |||
| ASA Class 1/2 |
71
30.2%
|
62
28.2%
|
133
29.2%
|
| ASA Class 3/4/5 |
164
69.8%
|
158
71.8%
|
322
70.8%
|
Outcome Measures
| Title | Number of Patients With Absence of Aneurysm Related Complications (ARC) |
|---|---|
| Description | ARC is a composite of the most relevant EVAR outcomes and includes: Peri-Operative Death (< 30 days) Rupture Conversion to OSR Endoleaks; post-operative Migration (≥ 10mm) Aneurysm Enlargement (≥ 5mm) Endograft Limb Occlusions Reinterventions for device- or aneurysm-related complications |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AFX EVAR AAA Graft System | FDA Approved EVAR AAA Graft Systems |
|---|---|---|
| Arm/Group Description | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems |
| Measure Participants | 235 | 220 |
| Count of Participants [Participants] |
195
83%
|
175
79.5%
|
| Title | The Number of MAEs |
|---|---|
| Description | Major Adverse Events |
| Time Frame | At 30 days, 12 months, and annually up to five years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | The Number of Aneurysm Related Complications (ARC) |
|---|---|
| Description | ARC is a composite outcome |
| Time Frame | Post 12 Months up to Five Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | The Number of Participants With Aneurysm Related Mortality |
|---|---|
| Description | Death related to the aneurysm |
| Time Frame | Up to Five Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Number of Endoleaks Classified by Type |
|---|---|
| Description | All Endoloeaks |
| Time Frame | Up to Five Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Loss of Neck Apposition as Measured by Length in mm |
|---|---|
| Description | Loss of Neck Apposition as measured by length in mm |
| Time Frame | Up to Five Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Number of AAA Related Secondary Procedures |
|---|---|
| Description | Number of AAA related secondary procedures |
| Time Frame | Up to Five Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Number of Device Integrity Events |
|---|---|
| Description | Number of device integrity events from device fractures and technical observations related to the stent graft |
| Time Frame | Up to Five Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Number of Adjunctive Procedures Necessitated During the Implant Procedure. |
|---|---|
| Description | Number of adjunctive procedures done during the implant procedure |
| Time Frame | Up to Five Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | AEs are collected through 5 year follow-up visit. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | AFX EVAR AAA Graft System | FDA Approved EVAR AAA Graft Systems | ||
| Arm/Group Description | Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. AFX EVAR AAA Graft System: Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access. | Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access. FDA Approved EVAR AAA Graft Systems | ||
All Cause Mortality |
||||
| AFX EVAR AAA Graft System | FDA Approved EVAR AAA Graft Systems | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 56/235 (23.8%) | 45/220 (20.5%) | ||
Serious Adverse Events |
||||
| AFX EVAR AAA Graft System | FDA Approved EVAR AAA Graft Systems | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 140/235 (59.6%) | 129/220 (58.6%) | ||
| Blood and lymphatic system disorders | ||||
| Bleeding | 14/235 (6%) | 15 | 16/220 (7.3%) | 19 |
| Cardiac disorders | ||||
| cardiac | 47/235 (20%) | 63 | 36/220 (16.4%) | 59 |
| Gastrointestinal disorders | ||||
| GI | 13/235 (5.5%) | 14 | 12/220 (5.5%) | 14 |
| General disorders | ||||
| Miscellaneous | 42/235 (17.9%) | 55 | 45/220 (20.5%) | 55 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Malignancies | 28/235 (11.9%) | 30 | 19/220 (8.6%) | 20 |
| Nervous system disorders | ||||
| neurological | 19/235 (8.1%) | 27 | 20/220 (9.1%) | 20 |
| Renal and urinary disorders | ||||
| Renal | 13/235 (5.5%) | 13 | 17/220 (7.7%) | 18 |
| Respiratory, thoracic and mediastinal disorders | ||||
| pulmonary | 34/235 (14.5%) | 45 | 26/220 (11.8%) | 44 |
| Skin and subcutaneous tissue disorders | ||||
| Wound | 4/235 (1.7%) | 4 | 6/220 (2.7%) | 8 |
| Vascular disorders | ||||
| Aneurysm Rupture | 0/235 (0%) | 0 | 0/220 (0%) | 0 |
| Device | 23/235 (9.8%) | 28 | 19/220 (8.6%) | 24 |
| Vascular | 26/235 (11.1%) | 35 | 30/220 (13.6%) | 38 |
Other (Not Including Serious) Adverse Events |
||||
| AFX EVAR AAA Graft System | FDA Approved EVAR AAA Graft Systems | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 51/235 (21.7%) | 56/220 (25.5%) | ||
| Blood and lymphatic system disorders | ||||
| anemia | 6/235 (2.6%) | 6 | 1/220 (0.5%) | 1 |
| Cardiac disorders | ||||
| Cardiac | 0/235 (0%) | 0 | 0/220 (0%) | 0 |
| Gastrointestinal disorders | ||||
| GI | 1/235 (0.4%) | 1 | 0/220 (0%) | 0 |
| General disorders | ||||
| miscellaneous | 3/235 (1.3%) | 3 | 2/220 (0.9%) | 2 |
| Nervous system disorders | ||||
| Neurological | 3/235 (1.3%) | 3 | 1/220 (0.5%) | 1 |
| Renal and urinary disorders | ||||
| Renal | 3/235 (1.3%) | 4 | 2/220 (0.9%) | 2 |
| Skin and subcutaneous tissue disorders | ||||
| wound | 0/235 (0%) | 0 | 1/220 (0.5%) | 1 |
| Vascular disorders | ||||
| Device | 36/235 (15.3%) | 37 | 42/220 (19.1%) | 44 |
| vascular | 7/235 (3%) | 7 | 9/220 (4.1%) | 9 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
PI shall be free to publish Institution's data/results from the Clinical Study at time of multicenter results published, notification that publication is not planned, or 18 months after the study conclusion at all centers, whichever occurs first.
Results Point of Contact
| Name/Title | Sharone Trifskin |
|---|---|
| Organization | Endologix, Inc. |
| Phone | 949-599-8860 |
| strifskin@endologix.com |
Responsible Party:
Endologix
ClinicalTrials.gov Identifier:
NCT02407457
Other Study ID Numbers:
- CP-0011
First Posted:
Apr 3, 2015
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021