JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions

Peripheral Vascular Disease Clinical Trial

— JetStreamISR  

Official title:

Safety and Effectiveness of JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions: A Prospective Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722877
• Other study ID #: JS-ISR-001, version 1, Rev 2
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: September 2015

Study information

• Verified date: February 2020
• Source: Midwest Cardiovascular Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis in the lower leg arteries but mixed results have been noted. In this study we hypothesize that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up.

Description:

Data not available yet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is 18 years of age or older.

2. Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal)

3. Subject presents with a Rutherford Classification of 1-5 and has symptoms of rest limb pain, ulcerations or claudication.

4. Target lesion(s) must be viewed angiographically and have =50% stenosis.

5. The atherectomy wire must be placed entirely across all lesions to be treated with no visible evidence of clear or suspected subintimal/substent wire passage.

6. The main target vessel reference diameter must be at least 5 mm.

7. One patent distal run-off vessel with brisk flow is required.

8. Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled instructions for use.

9. Patient has signed approved informed consent.

10. Patient is willing to comply with the follow-up evaluations at specified times.

Exclusion Criteria:

1. Subject is unable to understand the study or has a history of non-compliance with medical advice.

2. Subject is unwilling or unable to sign the Informed Consent Form (ICF).

3. Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints (e.g., limit use of study-recommended medications, etc.).

4. Subject is pregnant or planning to become pregnant within the study period.

5. Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for.

6. Subject is diagnosed with chronic renal failure or has a creatinine level > 2.5 mg/dl and is not on chronic dialysis.

7. Subject has a known allergy to heparin, ASA, Plavix.

8. Subject has a history of bleeding disorders or platelet count < 80,000 cells/ml.

9. Subject experiences ongoing cardiac problems (e.g., cardiac arrhythmias, congestive heart failure exacerbation, myocardial infarction, etc.) that, per the investigator, would not make the subject an ideal candidate for study procedures.

10. Subject has a CVA or TIA within 4 weeks prior to JetStream procedure.

11. Subject has an anticipated life span of less than 6 months.

12. Subject is suspected of having an active systemic infection.

13. Subject per the investigator's medical judgment must be excluded from the study.

14. Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).

15. Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.

16. Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.

17. Patient has any planned surgical intervention or endovascular procedure within 15 days after the index procedure.

18. Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System.

19. Use of another debulking device after the Jetstream NAVITUS system.

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Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Restenosis
• Vascular Diseases

Intervention

Device:
• JetStream Navitus
Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.

Locations

Country	Name	City	State
United States	Trinity Bettendorf Medical Center	Bettendorf	Iowa
United States	VA Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Midwest Cardiovascular Research Foundation	MEDRAD, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute Device Success	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.	intraprocedural
Primary	Acute Procedural Success	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.	intraprocedural
Secondary	Patency	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.	6 months
Secondary	Target Lesion Revascularization	Reintervention on the same index lesion at 6 months	6 months