## Protocol Section
### Identification Module
**NCT ID:** NCT02477579

**Brief Title:** A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions

**Official Title:** A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions

#### Organization Study ID Info
**ID:** NT-CLP-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Nitiloop Ltd.
### Status Module
#### Completion Date
**Date:** 2017-08-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-08-17

**Type:** ACTUAL

**Last Update Submit Date:** 2017-08-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-08-10

**Type:** ACTUAL

#### Start Date
**Date:** 2015-05-17

**Type:** ACTUAL

**Status Verified Date:** 2017-08

#### Study First Post Date
**Date:** 2015-06-23
**Type:** ESTIMATED
**Study First Submit Date:** 2015-06-17
**Study First Submit QC Date:** 2015-06-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Nitiloop Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.

**Detailed Description:** The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.

### Conditions Module

**Conditions:**

- Chronic Total Occlusion of Coronary Artery

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 145

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** NovaCross microcatheter will be used.

**Intervention Names:**

- Device: NovaCross

**Label:** NovaCross

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- NovaCross

**Description:** The NovaCross™ is a guidewire positioning and support microcatheter for improving chronic total occlusion (CTO) crossability. The NovaCross™ gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extendable segment, both at its distal tip.

**Name:** NovaCross

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 30 day MACE, defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).

**Measure:** MACE

**Time Frame:** 30 days

**Description:** Intra-procedural technical success, defined as the ability of the NovaCross™ micro-catheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion (CTO) in the true vessel lumen.

**Measure:** Intra-procedural technical success

**Time Frame:** Intra-procedure

#### Secondary Outcomes

**Description:** 1. The ability to cross the lesion with a guidewire in the true lumen, effectively dilate the CTO lesion, and place a coronary stent with residual lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow.

**Measure:** 1. The ability to cross the lesion with a guidewire in the true lumen, effectively dilate the CTO lesion, and place a coronary stent with residual lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow.

**Time Frame:** Procedure

**Description:** 2. The ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.

**Measure:** Proximal cap (ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.)

**Time Frame:** Procedure

**Description:** 3. The effectiveness of the extendable portion in intra-CTO microcatheter crossability.

**Measure:** Effectiveness of extendable portion (effectiveness of the extendable portion in intra-CTO microcatheter crossability)

**Time Frame:** Procedure

**Description:** 4. The ability to have full visualization of the NovaCross during the CTO procedure.

**Measure:** Visualization (ability to have full visualization of the NovaCross during the CTO procedure)

**Time Frame:** Procedure

**Description:** 5. Assess the usability of the NovaCross™ by the operator.

**Measure:** Usability (Assess the usability of the NovaCross™ by the operator)

**Time Frame:** Procedure

**Description:** 6. Device-related perforation at the site of target coronary lesion and/or its proximal reference segment.

**Measure:** Device-related perforation (at the site of target coronary lesion and/or its proximal reference segment)

**Time Frame:** Procedure

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult aged 25-80
* Patient understands and has signed the study informed consent form.
* Patient has an angiographic documented Chronic Total Occlusion (i.e. \>3 months occlusion duration) showing distal TIMI flow 0.
* Suitable candidate for non-emergent, coronary angioplasty
* Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches
* Body Mass Index (BMI) \< 40
* Left ventricle ejection fraction \> 25%

Exclusion Criteria:

* Patient unable to give informed consent.
* Current participation in another study with any investigational drug or device.
* Patient is known or suspected not to tolerate the contrast agent.
* Aorta-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent CTO.
* Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
* Appearance of a fresh thrombus or intraluminal filling defects.
* Recent major cerebrovascular event (history of stroke or TIA within 1 month)
* Cardiac intervention within 4 weeks of the procedure
* Renal insufficiency (serum creatinine of \> 2.3mg/dl or 203μmol/L)
* Active gastrointestinal bleeding
* Active infection or fever that may be due to infection
* Life expectancy \< 2 years due to other illnesses
* Significant anemia (hemoglobin \< 8.0 mg / dl)
* Severe uncontrolled systemic hypertension (\> 240 mmHg within 1 month of procedure)
* Severe electrolyte imbalance
* Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] CSA Class IV.
* Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
* Recent myocardial infarction (MI) (within the past two weeks)
* Uncontrolled diabetes \>2 serum glucose concentrations of \>350 mg/dl within 7 days.
* Unwillingness or inability to comply with any protocol requirements
* Pregnant or nursing
* Extensive prior dissection from a coronary guidewire use
* Drug abuse or alcoholism.
* Patients under custodial care.
* Bleeding diathesis or coagulation disorder;
* Kawasaki's disease or other vasculitis

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Little Rock

**Country:** United States

**Facility:** Central Arkansas Veterans Healthcare System

**State:** Arkansas

**Zip:** 72205

**Location 2:**

**City:** Naperville

**Country:** United States

**Facility:** Edward Hospital

**State:** Illinois

**Zip:** 60540

**Location 3:**

**City:** New York

**Country:** United States

**Facility:** Columbia University Medical Center/New York Presbyterian Hospital

**State:** New York

**Zip:** 10032

**Location 4:**

**City:** York

**Country:** United States

**Facility:** York Hospital

**State:** Pennsylvania

**Zip:** 17403

**Location 5:**

**City:** Krakow

**Country:** Poland

**Facility:** SPZOZ University Hospital in Krakow

#### Overall Officials

**Official 1:**

**Affiliation:** Belfast Health and Social Care Trust

**Name:** Simon Walsh, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Annotation Section

### Unposted Annotation

#### Event: RELEASE

- Date: 2019-12-04

- Date Unknown: Unknown

#### Event: RESET

- Date: 2019-12-18

- Date Unknown: Unknown

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2019-12-04

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2019-12-04

- Reset Date: 2019-12-18

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
