## Protocol Section
### Identification Module
**NCT ID:** NCT06434194

**Brief Title:** Serrantor OCT Study

**Official Title:** Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)

#### Organization Study ID Info
**ID:** CSP
#### Organization
**Class:** INDUSTRY
**Full Name:** Cagent Vascular LLC
### Status Module
#### Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Cagent Vascular LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

### Description Module

**Brief Summary:** TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.

### Conditions Module

**Conditions:**

- Critical Limb Ischemia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon

**Intervention Names:**

- Device: Serranator PTA Serration Catheter

**Label:** Serrantor

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon.

**Intervention Names:**

- Drug: PTA (Standard of Care)

**Label:** PTA

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Serrantor

**Description:** The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.

**Name:** Serranator PTA Serration Catheter

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- PTA

**Description:** A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.

**Name:** PTA (Standard of Care)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Residual lumen volume stenosis derived by OCT comparing Serration Angioplasty and conventional plain balloon angioplasty (PTA) measured at 10-15min post procedure. The lesion segment is defined as the entire treated segment where the balloon has been inflated.

**Measure:** Residual Lumen Volume Stenosis

**Time Frame:** Baseline

#### Secondary Outcomes

**Description:** Residual stenosis as measured by OCT

**Measure:** OCT Residual Diameter Stenosis

**Time Frame:** Baseline

**Description:** Residual stenosis as measured by angiography

**Measure:** Angiography Residual Diameter Stenosis

**Time Frame:** Baseline

**Description:** The incidence of dissection pattern between the study arms as reported by the OCT Corelab. The CoreLab will evaluate OCT images of each dissection including analysis of the length of the dissection, arc of the dissection, number of serrations, and the length of the serration.

**Measure:** Dissection Pattern

**Time Frame:** Baseline

**Description:** The correlation of the plaque modification achieved as determine from the OCT evaluation after treatment with the Study Device to the luminal gain achieved by conventional angioplasty as evaluated by the Core Lab.

**Measure:** Correlation of Luminal Gain and Plaque Modification

**Time Frame:** Baseline

**Description:** Rate of procedures that achieve optimal PTA (\<30% diameter stenosis without flow-limiting dissection measured by angiography)

**Measure:** Rate of Optimal PTA

**Time Frame:** Baseline

**Description:** Rate of bail-out stenting

**Measure:** Bail-out Stenting

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Rutherford clinical category 4-6 of the target limb
* Age of subjects is \>18 years old
* Patients has given informed consent to participate in this study

Exclusion Criteria:

* De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion
* Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.
* Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.
* Lesion length less than 220 mm

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kjclinconsulting@gmail.com

**Name:** Feeny

**Phone:** 4197878496

**Role:** CONTACT

**Contact 2:**

**Email:** twittwer@mededge.io

**Name:** Wittwer

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007511

- Term: Ischemia

- ID: D000010335

- Term: Pathologic Processes

- ID: D000058729

- Term: Peripheral Arterial Disease

- ID: D000050197

- Term: Atherosclerosis

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000016491

- Term: Peripheral Vascular Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M2714

- Name: Chronic Limb-Threatening Ischemia

- Relevance: HIGH

- As Found: Critical Limb Ischemia

- ID: M29213

- Name: Peripheral Arterial Disease

- Relevance: LOW

- As Found: Unknown

- ID: M18894

- Name: Peripheral Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26188

- Name: Atherosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000089802

- Term: Chronic Limb-Threatening Ischemia

### Misc Info Module

- Version Holder: 2024-05-31
