Trial Outcomes & Findings for JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions (NCT NCT01722877)

NCT ID: NCT01722877

Last Updated: 2020-03-03

Results Overview

Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: intraprocedural
• Results posted on: 2020-03-03

Participant Flow

29 patients with FP ISR in 32 limbs were treated at 2 medical centers by 2 operators from October 2012 to August 2014. Patients were eligible only if they had a more or equal 50% in-stent restenotic lesion in the superficial femoral or popliteal arteries (estimated diameter ≥5 mm), Rutherford category 1-5, and at least one patent runoff vessel.

Patients were excluded if they were not able to give informed consent, had a creatinine level >2.5 mg/dL, were unable to take antiplatelet drugs, or had a planned surgical or endovascular procedure within 15 days of the index procedure. After consenting, patient were excluded if had denovo disease or no in-stent restenosis in the target vessel.

Unit of analysis: limbs

Participant milestones

Measure	JetStream Atherectomy Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
Overall Study STARTED	29 32
Overall Study COMPLETED	27 29
Overall Study NOT COMPLETED	2 3

Reasons for withdrawal

Measure	JetStream Atherectomy Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
Overall Study Death	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	JetStream Atherectomy n=29 Participants Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery. Patients were eligible for the study only if they had a more or equal 50% in-stent restenotic lesion in the superficial femoral or popliteal arteries (estimated diameter ≥5 mm), Rutherford category 1-5 ischemia, and at least one patent infrapopliteal runoff vessel. Patients were excluded if they were not able to give informed consent, had a creatinine level \>2.5 mg/dL, were unable to take antiplatelet drugs, or had a planned surgical or endovascular procedure within 15 days of the index procedure.The JetStream was used as a first modality of treatment, no other debulking devices, cutting/scoring balloons, or cryogenic balloons were allowed.
Age, Continuous	69.9 years STANDARD_DEVIATION 11.7 • n=29 Participants
Sex: Female, Male Female	18 Participants n=29 Participants
Sex: Female, Male Male	11 Participants n=29 Participants
Region of Enrollment United States	29 Participants n=29 Participants

PRIMARY outcome

Timeframe: intraprocedural

Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.

Outcome measures

Measure	JetStream Atherectomy n=32 limbs Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. JetStream Navitus: Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.
Acute Procedural Success	29 limbs

SECONDARY outcome

Timeframe: 6 months

Population: Only 25 limbs had duplex ultrasound at 6 months.

Patency is defined as Peak Systolic Velocity Ratio (PSVR) of < 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion.

Outcome measures

Measure	JetStream Atherectomy n=25 limbs Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. JetStream Navitus: Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.
Patency	72 Percentage of patent limbs

SECONDARY outcome

Timeframe: 6 months

Reintervention on the same index lesion at 6 months

Outcome measures

Measure	JetStream Atherectomy n=29 lesions Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. JetStream Navitus: Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.
Target Lesion Revascularization	4 lesions

OTHER_PRE_SPECIFIED outcome

Timeframe: intraprocedural

Acute device success is defined as less than or equal to 50% residual stenosis at the index lesion using the JetStream device alone and with no adjunctive balloon angioplasty therapy (via Quantitative Vascular Analysis) and with no serious adverse events.

Outcome measures

Measure	JetStream Atherectomy n=29 limbs Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. JetStream Navitus: Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.
Acute Device Success	22 limbs

Adverse Events

JetStream Atherectomy

Serious events: 4 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	JetStream Atherectomy n=29 participants at risk Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
Vascular disorders Target lesion revascularization	13.8% 4/29 • Number of events 4 • 6 months Death

Other adverse events

Measure	JetStream Atherectomy n=29 participants at risk Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
Vascular disorders non target vessel revascularization	10.3% 3/29 • Number of events 3 • 6 months Death
Respiratory, thoracic and mediastinal disorders COPD exacerbation	6.9% 2/29 • Number of events 2 • 6 months Death

Additional Information

Dr Nicolas W Shammas

Midwest Cardiovascular Research Foundation

Phone: 5633200263

Email: shammas@mchsi.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place