Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA

NCT03455855 | Completed Results FDA Device

• 1 other identifier: S6050
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is a prospective, non-randomized, multicenter, single-arm study to demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System (Jetstream) used during percutaneous peripheral vascular intervention in patients with occlusive atherosclerotic lesions in the native SFA and/or PPA. It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Jetstream System.

Conditions

Atherosclerosis

Keywords

Atherectomy; occlusive atherosclerotic lesions

Outcome Measures

Primary Outcomes (2)

• The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter Stenosis

  Acute reduction of percent diameter stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis (absolute mean percentage).

  Index Procedure (Core-lab will analysis the procedural angiograms to assess the acute reduction of percent diameter stenosis (%DS))

• The Primary Safety Endpoint-The Rate of Major Adverse Event (MAE) at 30 Days Follow up

  defined as all-cause death, target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days post index procedure.

  30days

Study Arms (1)

treated with the Jetstream System

EXPERIMENTAL

It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Jetstream System.

Device: Jetstream System

Interventions

Jetstream System DEVICE

including Atherectomy Console (Jetstream Console) and Atherectomy Catheter(Jetstream Catheter), intended for use in atherectomy of the peripheral vasculature and to break apart and remove atherosclerotic disease, debris, and thrombus from the SFA and/or PPA.

treated with the Jetstream System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects age 18 and older
• Subject or the subject's legal representative is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits
• Subject has documented chronic, symptomatic lower limb ischemia defined as Rutherford categories 2 - 4, and is eligible for percutaneous peripheral vascular intervention
• Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA, and meet all of following angiographic criteria by visual assessment:
• i. Atherosclerotic lesion with diameter stenosis ≥70% ii. Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course by physicians performed, based on visual estimate iii. Minimum vessel diameter proximal to the lesion ≥ 3 mm and \< and =6 mm iv. Lesion length of single or multiple focal stenosis or chronic total occlusion (CTO) lesion can be up to 15 cm long v. Target lesion located at least 3 cm above the inferior edge of the femur
• Patent infrapopliteal and popliteal artery, i.e., single distal runoff or better with at least one of three vessels patent (\< 50% stenosis by visual assessment) to the ankle or foot with no planned intervention

You may not qualify if:

• Target lesion is located in the iliac artery or above the SFA
• Target lesion stenosis \< 70%
• Target lesion is moderately to severely angulated (\> 30°) or torturous at treatment segment
• Target lesion/vessel previously treated with drug-coated balloon within 12 months prior to the index procedure
• Target lesion/vessel previously treated with atherectomy, laser or other debulking devices prior to the index procedure
• Target lesion/vessel with in-stent restenosis
• Subjects who have undergone prior surgery or endovascular intervention of SFA/PPA in the target limb to treat atherosclerotic disease within 3 month prior to the index procedure
• Use of drug-coated devices, or laser or any other debulking devices other than Jetstream System (such as CTO devices or cutting balloon) in the target limb during the index procedure
• History of major amputation in the target limb
• Documented life expectancy less than 12 months due to other medical co-morbid condition(s)
• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated
• Known history of coagulopathy or hypercoagulable bleeding disorder
• Known hypersensitivity/allergy to the investigational devices or protocol related therapies (e.g., nitinol, stainless steel or other stent materials, and antiplatelet, anticoagulant, thrombolytic medications)
• Platelet count \< 80,000 mm3 or \> 600,000 mm3 or history of bleeding diathesis
• Undergoing hemodialysis or concomitant renal failure with a serum creatinine \> 2.0 mg/dL (176.8umol/L)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100024, China

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr Haotian Zhang
• Organization: Boston Scientific

haotian.zhang@bsci.com

+8617621154031

Study Officials

• Wei Guo

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2018
• First Posted: March 7, 2018
• Study Start: March 5, 2018
• Primary Completion: February 22, 2023
• Study Completion: January 27, 2024
• Last Updated: October 29, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-10

Locations

CN (1)