Trial Outcomes & Findings for JetStream Atherectomy for the Treatment of In-stent Restenosis (NCT NCT02730234)

NCT ID: NCT02730234

Last Updated: 2021-08-11

Results Overview

TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-08-11

Participant Flow

Participant milestones

Measure	JetStream XC With Balloon Angioplasty The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.
Overall Study STARTED	60
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

JetStream Atherectomy for the Treatment of In-stent Restenosis

Baseline characteristics by cohort

Measure	JetStream XC With Balloon Angioplasty n=60 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants
Age, Continuous	70.2 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Race/Ethnicity, Customized white	51 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants
Race/Ethnicity, Customized African American	8 participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants
Body Mass Index	28.4 kg/m^2 STANDARD_DEVIATION 6.0 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 5 people died at 6 months. 1 patient had TLR before death and was counted in the TLR analysis. 4 patients were not analyzed at 6 months as they were dead before a TLR occurred (censored). So these 4 patients were excluded from the analysis at 6 months.

TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis)

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=56 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Percentage of Participants With Target Lesion Revascularization (TLR)

12 Participants

PRIMARY outcome

Timeframe: 30 days

Population: All patients were analyzed.

unplanned major amputation, all cause mortality, and Bailout Stenting consider Target Lesion Revascularization (TLR).

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=60 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Major Adverse Events (MAE)

6 Participants

SECONDARY outcome

Timeframe: Intraprocedural

Population: 15 patients did not have interpretable angiographic films by core lab

Categorized by < 50% residual stenosis following JS atherectomy alone and without additional adjunctive PTA or bail out procedures as determined by the Angiographic Core Laboratory.

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=45 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Device Outcome

25 Participants

SECONDARY outcome

Timeframe: Intraprocedural

Population: 11 patients with angiogram not interpretable by core lab

Defined as ≤30% residual diameter stenosis following JS + PTA without provisional or bailout procedures

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=49 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Procedural Success

35 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 5 patients died after hospital discharge out of 60 patients

TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. Intra-procedural bail out stenting of the index lesion is NOT considered meeting a TLR endpoint. (ITT analysis)

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=55 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Target Lesion Revascularization (TLR) With no Bailout Stent Included

6 Participants

SECONDARY outcome

Timeframe: 1 year

Population: 8 patients died at 1 year before TLR occurred and so censored out.

TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 1 year ITT (bail out stent in the Lab is not considered as TLR)

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=52 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Target Lesion Revascularization (TLR)

18 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 20 patients either died or had no duplex US at 6 month to assess patency

Defined as PSVR ≤ 2.5 at the treated site or < 50% stenosis by angiography as determined by the Angiographic Core Laboratory in the absence of TLR, amputation, and/or surgical bypass (the evaluation of patency is extended to one cm proximal and one cm distal to the target lesion)

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=40 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Clinical Patency

31 Participants

SECONDARY outcome

Timeframe: 1 year

Population: 41 patients either died or did not have a Duplex Ultrasound to assess for patency at 1 year

Defined as PSVR ≤ 2.5 at the treated site or < 50% stenosis by angiography as determined by the Angiographic Core Laboratory in the absence of TLR, amputation, and/or surgical bypass (the evaluation of patency is extended to one cm proximal and one cm distal to the target lesion)

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=29 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Clinical Patency

15 Participants

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Data not available on 12 patients that either died or test not performed

Defined as the change in mean Walking Impairment Questionnaire (WIQ) score at 6 months minus baseline. WIQ score range is 0 to 56. A higher score means a better outcome. WIQ is reported as a change between baseline and 6 months in the score (WIQ score at 6 months minus WIQ score at baseline)

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=48 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Change in Walking Impairment Questionnaire Score

21.8 score on a scale Interval 12.9 to 34.5

SECONDARY outcome

Timeframe: 6 months

Population: 38/49 77.5% participants showed improvment by at least 1 category at 6 months

Defined as the change in clinical status indicated by the number of participants that had one improvement of their Rutherford Becker category by at least 1 category at 6 months. The Rutherford category is done on a scale of 0 (no symptoms) to 6 (gangrene/ulceration). A change downward from one category to another is considered an improvement.

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=49 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Number of Participants With Rutherford Clinical Category Improvement

38 participants

SECONDARY outcome

Timeframe: 6 months

Population: The change in ABI at 6 months is a mean of 0.2+/- 0.3.

Defined as the mean ankle-brachial index (ABI) at 6 months minus mean ABI at baseline in subjects with compressible arteries and baseline ABI < 0.9 (0 to 1.2 is the scale ranging from severe disease to normal respectively; higher is better).

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=38 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Change in Ankle-Brachial Index

0.2 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 1 Year

Population: 38.7 % improvement from baseline to 1 year.

Defined as the change in mean Walking Impairment Questionnaire (Score 0 to 56. A higher score means a better outcome) from Baseline minus at one Year.

29.2-48.8 is the confidence interval minimum and maximum values.

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=43 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Change in Walking Impairment Questionnaire at 1 Year

38.7 score on a scale Standard Deviation 10.0

SECONDARY outcome

Timeframe: 1 Year

Population: 17 patients either died or Rutherford Category was not assessed due to no office visit or not evaluated.

Defined as the change in clinical status indicated by the change in Rutherford Becker Class at 1 Year compared to baseline by at least one category that is attributable to the treated limb (in cases of bilateral disease).

Categories are 0 which is asymptomatic to 6 which is gangrene. (Rutherford Becker Category:0=Asymptomatic, 1 = Mild Claudication, 2=moderated claudication, 3= severe claudication, 4= resting pain, 5= ulcers, 6= ulcers with gangrene.

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=43 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Rutherford Clinical Category

35 Participants

SECONDARY outcome

Timeframe: 1 Year

Population: 29 patients missing because of death or ABI not obtained at visit or visit did not occur

Defined as the change in mean ankle-brachial index (ABI) at 1 Year minus mean ABI at baseline in subjects with compressible arteries and baseline ABI < 0.9. Units on a Scale: 0 to 1.2 (worse to normal respectively)

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=31 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Ankle Brachial Index

0.2 units on a scale Interval 0.2 to 0.3

SECONDARY outcome

Timeframe: 6 months

Population: 8/45 experienced CD TLR (by KM)

Clinically-driven TLR (CD-TLR) at 6 months was defined as any reintervention or bypass graft surgery involving a target lesion with a ≥70% diameter stenosis by angiography or PSVR >3.5 and at least 2 of the following associated events: ≥1-level worsening of the Rutherford category, worsening WIQ score by ≥20 points, or an ABI drop >0.15 between baseline and follow-up.

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=45 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Clinically Driven Target Lesion Revascularization

8 Participants

SECONDARY outcome

Timeframe: 12 months

Population: 11/32 experienced CD-TLR at 1 year

Clinically-driven TLR (CD-TLR) was defined as any reintervention or bypass graft surgery involving a target lesion with a ≥70% diameter stenosis by angiography or PSVR >3.5 and at least 2 of the following associated events: ≥1-level worsening of the Rutherford category, worsening WIQ score by ≥20 points, or an ABI drop >0.15 between baseline and follow-up.

Outcome measures

Measure

JetStream XC With Balloon Angioplasty n=32 Participants The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.

Clinically Driven Target Lesion Revascularization

11 Participants

Adverse Events

JetStream XC With Balloon Angioplasty

Serious events: 21 serious events

Other events: 15 other events

Deaths: 8 deaths

Serious adverse events

Measure	JetStream XC With Balloon Angioplasty n=60 participants at risk The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.
Vascular disorders Target Lesion Revascularization with Bailout Stenting	35.0% 21/60 • Number of events 21 • Major Adverse Events were collected for up to 1 year Definition are consistent with clinicaltrials.gov definition for AE and SAE
Vascular disorders Target Lesion Revascularization without Bailout Stenting	18.3% 11/60 • Number of events 11 • Major Adverse Events were collected for up to 1 year Definition are consistent with clinicaltrials.gov definition for AE and SAE
Vascular disorders Unplanned Major amputation	0.00% 0/60 • Major Adverse Events were collected for up to 1 year Definition are consistent with clinicaltrials.gov definition for AE and SAE
Vascular disorders New Stent Fracture or Disruption	0.00% 0/60 • Major Adverse Events were collected for up to 1 year Definition are consistent with clinicaltrials.gov definition for AE and SAE
Vascular disorders Device Induced Vascular Injury	0.00% 0/60 • Major Adverse Events were collected for up to 1 year Definition are consistent with clinicaltrials.gov definition for AE and SAE
Vascular disorders Distal Embolization	13.3% 8/60 • Number of events 8 • Major Adverse Events were collected for up to 1 year Definition are consistent with clinicaltrials.gov definition for AE and SAE
Blood and lymphatic system disorders Major Bleeding	1.7% 1/60 • Number of events 1 • Major Adverse Events were collected for up to 1 year Definition are consistent with clinicaltrials.gov definition for AE and SAE
Cardiac disorders Nonfatal myocardial Infarction	1.7% 1/60 • Number of events 1 • Major Adverse Events were collected for up to 1 year Definition are consistent with clinicaltrials.gov definition for AE and SAE

Other adverse events

Measure	JetStream XC With Balloon Angioplasty n=60 participants at risk The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.
Cardiac disorders Angina	6.7% 4/60 • Number of events 60 • Major Adverse Events were collected for up to 1 year Definition are consistent with clinicaltrials.gov definition for AE and SAE
Vascular disorders worsening claudication in non affected limb	18.3% 11/60 • Number of events 60 • Major Adverse Events were collected for up to 1 year Definition are consistent with clinicaltrials.gov definition for AE and SAE

Additional Information

Nicolas W Shammas

Midwest Cardiovascular Research Foundation

Phone: 5633242828

Email: shammasg@mcrfmd.com

Results disclosure agreements

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