Absolute Pro® MOMENTUM™

Peripheral Artery Disease Clinical Trial

— MOMENTUM  

Official title:

Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent Systems in the Treatment of Subjects With Atherosclerotic De Novo or Restenotic Lesions in the Native Superficial Femoral Artery and/or Native Proximal Popliteal Artery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444378
• Other study ID #: 10-110
• Status: Completed
• Phase: N/A
• First received: September 21, 2011
• Last updated: May 12, 2015
• Start date: October 2011
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the treatment of subjects with atherosclerotic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or the native proximal popliteal artery (PPA).

CAUTION: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent Systems are investigational devices. Limited by Federal (U.S.) law to investigational use only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: May 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

General Clinical Inclusion Criteria:

1. Subject is = 18 years of age.

2. Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.

3. Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.

4. Subject is diagnosed as having moderate to severe claudication (Rutherford-Becker Clinical Category 2-3) or ischemic rest pain (Rutherford-Becker Clinical Category 4).

5. Female subject of childbearing potential must:

• have had a negative pregnancy test (serum HCG) within 14 days before treatment;

• not be nursing at the time of treatment; and

• agree at time of consent to use birth control during participation in this trial.

6. Subject has life expectancy > 12 months.

Angiographic Inclusion Criteria:

1. A single de novo or restenotic [not previously treated with stent, brachytherapy, laser, surgical bypass, or endarterectomy] native disease segment of the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) located within the following parameters: =1 cm below the femoral bifurcation in the SFA. =3 cm above the proximal margin of the intercondylar fossa.

2. Disease segment length visually estimated to be = 14 cm (140 mm) and can be treated with one stent.

3. Disease segment visually estimated to be = 50% stenosis or a total occlusion.

4. Target vessel reference diameter visually estimated to be = 4.0 mm and = 7.0 mm.

5. A patent ipsilateral iliac artery, defined as < 50% stenosis, as confirmed by arteriography.

6. At least one patent distal outflow artery (anterior tibial, posterior tibial, peroneal) defined as < 50% stenosis, that provides in-line circulation to the lower leg and foot.

7. Total occlusion length = 8 cm.

General Clinical Exclusion Criteria:

1. Subject is unable to walk.

2. Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, < 30 days prior to the planned index procedure.

3. Subject has received, or is on the waiting list for, a major organ transplant.

4. Subject is diagnosed as Rutherford-Becker Clinical Category 5 or 6 in either extremity.

5. Subject is diagnosed as Rutherford-Becker Clinical Category 0 or 1 in the target extremity (i.e., where the investigational stent will be placed).

6. Subject has elevated serum creatinine > 2.5 mg/dl.

7. Subject is on chronic hemodialysis.

8. Subject has documented or suspected uncontrolled diabetes mellitus (DM), unless HbA1c has been assessed as < 7.0% within 3 months prior to index procedure.

9. Subject has had a myocardial infarction (MI) within the previous 30 days of the planned index procedure.

10. Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the subject's ability to walk.

11. Subject has unstable angina defined as rest angina with ECG changes.

12. Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment.

13. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.

14. Subject is unable to take required antiplatelet therapy or requires any planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel, ticagrelor or ticlopidine within 30 days following the procedure.

15. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation or is associated with limited life-expectancy, i.e., less than 1 year.

16. Subject is currently participating in an investigational drug, biologic, or device study.

17. Subject is unable to understand or unwilling to cooperate with study procedures.

18. Subject is allergic to nickel, titanium, platinum, contrast media, or any study-required medication that is not amenable to pre-treatment.

19. Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hgb < 8.0) that cannot be corrected.

20. Subject requires general anesthesia for the procedure.

21. Subject has ischemic or neuropathic ulcers on either foot.

22. Subject has had any type of amputation to the ipsilateral extremity, or a contralateral extremity amputation other than of the toe or forefoot.

23. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

1. Total occlusion of the ipsilateral iliac artery.

2. Target extremity has multilevel disease that requires other staged procedures within 30 days before or after the procedure.

3. Target extremity has been previously treated with any of the following: surgical bypass or endarterectomy.

4. Target vessel has an angiographically significant (> 50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure within 30 days before or after the procedure.

5. Target vessel has been previously treated at any location with a stent, or has been previously treated = 5 cm from the proximal or distal margin of the target lesion with brachytherapy or laser.

6. Target lesion is within or adjacent to an aneurysm.

7. Target lesion or vessel has angiographic evidence of thrombus that is unresponsive to anti-thrombotic therapies.

8. Subject has a contralateral superficial femoral or proximal popliteal artery lesion that requires treatment within 30 days before or after the procedure.

9. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3 cm.

10. Subject has evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion.

11. .Subject has any condition that precludes safe access to the target lesion or target vessel, e.g. severe calcification, excessive tortuosity.

12. Target lesion requires use of re-entry, ablative, cutting balloon, atherectomy, or similar devices to cross or treat the lesion.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems
Stenting of the SFA and/or proximal popliteal artery using either of these devices.

Locations

Country	Name	City	State
United States	Abbott Vascular	Santa Clara	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary safety endpoint is freedom from major adverse event (MAE)	MAE defined as a composite of: Death due to all causes; Index limb major amputation (at or above the ankle); Clinically-driven target lesion revascularization (TLR)	30 days	Yes
Primary	Primary effectiveness endpoint is vessel patency	Defined as the absence of in-stent restenosis (= 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR.	12 months	No
Secondary	Device success	Defined as, on a per device basis, as the achievement of successful delivery and deployment of the trial device at the intended target lesion and successful withdrawal of the delivery catheter.	From start of index procedure to end of index procedure (Day 0)	No
Secondary	Technical success	Defined on a per lesion basis as the attainment of a final residual stenosis of < 30% by core laboratory assessment at the intended target lesion(s).	From start of index procedure to end of index procedure (Day 0)	No
Secondary	Clinical Success	Clinical success, defined on a per subject basis, as the attainment of a final residual stenosis of < 30% by core laboratory assessment using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications.	Within 2 days after the index procedure or at hospital discharge, whichever is sooner	Yes
Secondary	Ankle brachial index (ABI)/Toe Brachial Index (TBI) for the treated limb		1 month	No
Secondary	Ankle brachial index (ABI)/Toe Brachial Index (TBI) for the treated limb		6 months	No
Secondary	Ankle brachial index (ABI)/Toe Brachial Index (TBI) for the treated limb		12 months	No
Secondary	Walking capacity	Measured by the Walking Impairment Questionnaire (WIQ)	1 month	No
Secondary	Walking capacity	Measured by the Walking Impairment Questionnaire (WIQ)	6 months	No
Secondary	Walking capacity	Measured by the Walking Impairment Questionnaire (WIQ)	12 months	No
Secondary	Clinically-driven target lesion revascularization (TLR)		1 month	No
Secondary	Clinically-driven target lesion revascularization (TLR)		6 months	No
Secondary	Clinically-driven target lesion revascularization (TLR)		12 months	No
Secondary	Primary stent patency	Defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.	1 month	No
Secondary	Primary stent patency	Defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.	12 months	No
Secondary	Vessel patency	Defined as the absence of in-stent restenosis (= 50%) as determined by duplex ultrasound or arteriography and without clinically-driven TLR	1 month	No
Secondary	Stent integrity	Absence of stent fractures as determined by x-ray.	12 months	No
Secondary	Rutherford-Becker Clinical category for the treated limb		1 month	No
Secondary	Rutherford-Becker Clinical category for the treated limb		6 months	No
Secondary	Rutherford-Becker Clinical category for the treated limb		12 months	No
Secondary	Target lesion revascularization (TLR)		1 month	No
Secondary	Target lesion revascularization (TLR)		6 months	No
Secondary	Target lesion revascularization (TLR)		12 months	No
Secondary	Target vessel revascularization (TVR) for the treated limb		1 month	No
Secondary	Target vessel revascularization (TVR) for the treated limb		6 months	No
Secondary	Target vessel revascularization (TVR) for the treated limb		12 months	No
Secondary	Death (all cause)		1 month	Yes
Secondary	Death (all cause)		6 months	Yes
Secondary	Death (all cause)		12 months	Yes
Secondary	Amputations (minor and major) of the treated limb		Immediately post index procedure on Day 0 to the time of discharge	Yes
Secondary	Amputations (minor and major) of the treated limb		1 month	Yes
Secondary	Amputations (minor and major) of the treated limb		6 months	Yes
Secondary	Amputations (minor and major) of the treated limb		12 months	Yes
Secondary	Stent thrombosis (as reported by site)		In-hospital	Yes
Secondary	Stent thrombosis (as reported by site)		1 month	Yes
Secondary	Embolic events in the treated limb (as reported by site)		1 month	Yes
Secondary	Embolic events in the treated limb (as reported by site)		12 months	Yes
Secondary	Changes in Quality of Life Measures	SF-12® Health Survey	1 month	No
Secondary	Changes in Quality of Life Measures	SF-12® Health Survey	6 months	No
Secondary	Changes in Quality of Life Measures	SF-12® Health Survey	12 months	No
Secondary	Death (all cause)		Within 2 days after the index procedure or at hospital discharge, whichever is sooner	Yes
Secondary	Changes in Quality of Life Measures	VASCUQOL	1 month	No
Secondary	Changes in Quality of Life Measures	VASCUQOL	6 months	No
Secondary	Changes in Quality of Life Measures	VASCUQOL	12 months	No
Secondary	Stent Occlusion		6 months	Yes
Secondary	Stent Occlusion		12 months	Yes