A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base DCB (DEEPER LIMUS)
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|ClinicalTrials.gov Identifier: NCT04162418|
Recruitment Status : Recruiting
First Posted : November 14, 2019
Last Update Posted : August 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Critical Limb Ischemia||Device: Temporary Spur Stent System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Non-RanDomized Pilot Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base Drug-coated Balloon (DEEPER LIMUS)|
|Actual Study Start Date :||February 14, 2020|
|Estimated Primary Completion Date :||December 14, 2020|
|Estimated Study Completion Date :||January 14, 2021|
Treatment with Temporary Spur Stent System and a commercially available, limus-base, drug coated balloon
Device: Temporary Spur Stent System
Treatment of qualifying infrapopliteal lesions with Temporary Spur Stent System and a commercially available, limus-base drug-coated balloon
- Rate of All-Cause Mortality, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR) at 6 months [ Time Frame: 6 months ]6 month composite of All-Cause Mortality, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)
- Secondary Efficacy: Late lumen loss [ Time Frame: 6 months ]Late Lumen Loss (LLL) of the target lesion by angiogram/QVA at 6 months
- Secondary Efficacy: Primary Patency [ Time Frame: 6 months ]2. Primary patency (flow/no flow) of treated lesion sites by angiogram/QVA in subjects who are free from CD-TLR at 6 months.
- Secondary Efficacy: Rutherford class [ Time Frame: 12 months ]
The second secondary efficacy measurement is change in Rutherford class score at 3, 6 and 12 months. Rutherford score is a classification system for patients with peripheral vascular disease.
Categories are numbered from 0 to 6, with 0 being asymptomatic, and 6 being major tissue loss, functional foot no longer salvageable. Higher values are therefore considered a worse outcome.
Rutherford class zero: No symptoms; Rutherford class 1: Mild Claudication (minimal leg pain with ambulation) symptoms; Rutherford Class 2: Moderate Claudication (moderate leg pain with ambulation); Rutherford Class 3: Severe claudication (severe leg pain with ambulation); Rutherford Class 4: Ischemic Rest pain (leg pain at rest); Rutherford Class 5: Minor tissue loss (nonhealing ulcer, focal gangrene, diffuse pedal ischemia); Rutherford class 6: Major tissue loss (extending above the transmetatarsal TM level, functional foot no longer salvageable.
- Secpndary Efficacy: Wound healing [ Time Frame: 12 months ]
The third secondary efficacy endpoint is wound healing for subjects with Rutherford class 5 at 6 and 12 months, as assessed by the investigator using WIfI score and descriptive characteristics, including change in wound size measured by any decrease in wound surface area.
The WIfI classification scoring system is a grading system using a composite score of wound (W), ischemia (I), and foot infection (fi). These three different categories are graded from 0 to 3 with 0 being the best and 3 being the worst.
The total score will be provided (clinical stage 1-5), which is used to estimate the risk for major amputation at one year. Patients with a score of 1 are considered low risk, and patients with a score of 5 are considered high risk (foot not salvageable). Therefore, higher values are considered a worse outcome.
The composite score is calculated by adding up the score from each category.
- Secondary Safety: 30 days [ Time Frame: 30 days ]1. Freedom from target limb Major Adverse Limb Event (MALE) & All- cause perioperative death (POD) at 30 days
- Secondary Safety: 6 and 12 months [ Time Frame: 12 months ]Freedom from MALE of the target limb at 6 and 12 months post-procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04162418
|Contact: Carolyn Mascho, DNPfirstname.lastname@example.org|
|Univ.-Klinikum LKH Graz||Recruiting|
|Graz, Austria, 8036|
|Contact: Claudia Woehrer, BSc 004331638581110 email@example.com|
|Principal Investigator: Marianne Brodmann, MD|
|Principal Investigator:||Marianne Brodmann, MD||Univ-Klinikum LKH Graz|